Pharmaceutical and Medical Science Books

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Landmark 20th Edition

In an increasingly complex world of medicine, Harrison’s 20th edition is more relevant than ever, with a refreshed, user-friendly design and cutting-edge content that reflects the foundational, bioscientific, and clinical insights across the full spectrum of medicine.

Essential for Both Practice and Education

End-of-chapter suggested readings reinforce the text material and provide a robust platform for further study and research.

Brand new and up to date topics

New sections include sex and gender-based Issues in medicine; obesity, diabetes mellitus, metabolic syndrome; consultative medicine and more.

 

Part 1: The Profession of Medicine 

• Chapter 1: The Practice of Medicine
• Chapter 2: Promoting Good Health
• Chapter 3: Decision-Making in Clinical Medicine
• Chapter 4: Screening and Prevention of Disease
• Chapter 5: Health Care Systems in Developed Countries
• Chapter 6: The Safety and Quality of Health Care
• Chapter 7: Racial and Ethnic Disparities in Health Care
• Chapter 8: Ethical Issues in Clinical Medicine
• Chapter 9: Palliative and End-of-Life Care

 

•  Part 2: Cardinal Manifestations and Presentation of Diseases
•  Part 3: Pharmacology
•  Part 4: Oncology and Hematology
•  Part 5: Infectious Diseases
•  Part 6: Disorders of the Cardiovascular System
•  Part 7: Disorders of the Respiratory System
•  Part 8: Critical Care Medicine
•  Part 9: Disorders of the Kidney and Urinary Tract
•  Part 10: Disorders of the Gastrointestinal System
•  Part 11: Immune-Mediated, Inflammatory, and Rheumatologic Disorders
•  Part 12: Endocrinology and Metabolism
•  Part 13: Neurologic Disorders
•  Part 14: Poisoning, Drug Overdose, and Envenomation
•  Part 15: Disorders Associated with Environmental Exposures
•  Part 16: Genes, the Environment, and Disease
•  Part 17: Global Medicine
•  Part 18: Aging
•  Part 19: Consultative Medicine
•  Part 20: Frontiers
•  Part 21: Video Collection
  • Chapter V1: Video Library of Gait Disorders
  • Chapter V2: Primary Progressive Aphasia, Memory Loss, and Other Focal Cerebral Disorders
  • Chapter V3: Video Library of Neuro-Ophthalmology
  • Chapter V4: Examination of the Comatose Patient
  • Chapter V5: Video Atlas of Gastrointestinal Endoscopic Lesions
  • Chapter V6: The Neurologic Screening Exam
  • Chapter V7: Video Atlas of the Detailed Neurologic Examination
•  Part 22: Supplementary Topics

 

 

EDITORS :

J. Larry Jameson, MD, PhD

 

Dennis L. Kasper, MD

 

Dan L. Longo, MDAnthony S. Fauci, MD

 

Stephen L. Hauser, MD

 

Robert A. Fishman Distinguished Professor, Department of

 

Neurology; Director, UCSF Weill Institute for Neurosciences,

 

University of California, San Francisco,

 

San Francisco, California

 

Joseph Loscalzo, MD, PhD

 

Hersey Professor of the Theory and Practice of Medicine,

 

Harvard Medical School; Chairman, Department of Medicine;

 

Physician-in-Chief, Brigham and Women's Hospital, Boston,

 

Massachusetts

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The world’s most comprehensive reference source about drugs and medicines
The new edition of Martindale: The Complete Drug Reference, provides you with practical, evidence-based, global guidance, allowing you to quickly understand the characteristics of drugs and their clinical uses.
Over 120 new monographs include:
•  New antibacterials, such as delafloxacin, eravacycline, omadacycline, ozenoxacin, and plazomicin
•  Further antivirals, including drugs active against HIV (bictegravir, dapivirine, doravirine, ibalizumab), smallpox (tecovirimat), cytomegalovirus (letermovir), influenza (baloxavir marboxil), and hepatitis C (glecaprevir, pibrentasvir, voxilaprevir)
•  New treatment options for migraine (erenumab, fremanezumab, galcanezumab), narcolepsy (solriamfetol), hyperkalaemia (sodium zirconium cyclosilicate), postpartum depression (brexanolone), eosinophilic asthma (benralizumab), hypoactive sexual desire disorder (bremelanotide), glaucoma (netarsudil), African trypanosomiasis (fexinidazole), and irritable bowel syndrome (tenapanor)
•  New antidiabetic drugs, including ertugliflozin, evogliptin, semaglutide, and sotagliflozin
•  Further antineoplastics for treating cancers including PARP inhibitors (niraparib, rucaparib, talazoparib), PI3K inhibitors (alpelisib, copanlisib, duvelisib), and CAR-T therapies (axicabtagene ciloleucel, tisagenlecleucel)
•  Novel targeted treatments for retinal dystrophy (voretigene neparvovec), neurotrophic keratitis (cenegermin), paroxysmal nocturnal haemoglobinuria (ravulizumab), hereditary transthyretin amyloidosis (inotersen, patisiran), spinal muscular atrophy (nusinersen), and hereditary angioedema (lanadelumab)
Updated coverage of proprietary preparations in 43 countries including Australia, China, UK, and USA
Martindale: The Complete Drug Reference is a one-stop authoritative, invaluable reference work covering all aspects of drugs and medicines, essential on any bookshelf. It provides you with:
•  Over 6,400 drug monographs summarising the nomenclature, properties, and actions of each substance – all in one book, giving you quick and easy access•  Over 125,000 preparations from 43 countries and regions•  Nearly 700 treatment reviews, with references from the published literature•  5,600 + pharmaceutical terms and routes of administration in 13 major European languages•  Over 60,000 reference citations and over 25,000 international manufacturers and distributors•  Herbals, diagnostic agents, radiopharmaceuticals, pharmaceutical excipients, toxins, poisons

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Description

For the past 50 years, the Association of Physicians of India (API) has been regularly publishing the API Textbook of Medicine. 11th Ed is Published in 2019

This book will meet the needs of the medical students and practicing clinicians. This book contains up-to-date information about the physiological, pathological, biological and clinical aspects of diseases with special stress laid on their Indian features and information collected from available Indian data. The book therefore is truly “Made in India”, but “Global” in perspective.

The theme of the book is “from bedside to the bench to clinical management of cases”. All the latest advances have been incorporated in this book and the contents have been modified and made as contemporary as possible.

The Highlights of the Book are:

• Expansion of the Section “Clinical Approach” with incorporation of all the commonly seen clinical problems in the medical wards. Clinical cases and examples have been highlighted in many chapters. This will appeal to the medical students and the practicing clinicians.

• The section on “Infectious Diseases” o Being a book published in India, a detailed description of the common infections and infestations prevalent in our country is available. I o In addition, emerging infections like H1N1 influenza, SARS have been adequately covered, so also Zika virus and Nipah Virus infections. • Travel Medicine has emerged as an important subspeciality and therefor given due weightage in this edition.

• In the very last section are grouped various topics that are emerging subspecialities. They are Travel Medicine, Futuristic Medicine, Regenerative Medicine, Insurance Medicine, Communication Skills and Medical Ethics. The landmark judgement of the Supreme Court (2018) for “end of life decisions” has been very well elaborate in the chapter of “Palliative Medicine”.

• “Environment” is an important and topical subject today. A balanced environment will help in prevention and control of most lifestyle and communicable diseases. This has been taken into consideration when formulating the section on “Environmental Medicine The readers will definitely appreciate the in-depth description of diseases given by each author. The authors have been invited from all parts of the country – Kashmir to Kanyakumari and Gujarat to the Northeast States have been represented. This book will be useful for students, physicians and as a reference book for clinicians from other specialties like surgery, obstetrics and Gynaecology, orthopaedics, ENT, ophthalmology, community medicine and others.

Even paediatricians will find this book worth reading.

API Textbook Of Medicine – 11th Edition – ContentsVOLUME 1 :

Introduction
Section 1 : Epidemiology
Section 2 : Clinical Approach
Section 3 : Infectious Diseases
Section 4: HIV Medicine
Section 5: Medical Genetics
Section 6 : Immunology
Section 7 : Rheumatology
Section 8: Nutrition
Section 9: Metabolism
Section 10: Bone Disorders
Section 11: Endocrinology
Section 12: Diabetology
Section 13: Haematology
Section 14: Oncology
Section 15: Nephrology
Section 16: Environmental Medicine

VOLUME 2 :

Section 17: Pulmonology
Section 18: Cardiology
Section 19: Gastroenterology
Section 20: Hepatology
Section 21: Neurology
Section 22: Psychiatric Medicine
Section 23: Critical Care Medicine
Section 24: Poisoning & Toxicology
Section 25: Diagnostic Imaging
Section 26: Gerontology
Section 27: Other Specialities

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Compiled by the Inspection, Enforcement and Standards Division, Medicines and Healthcare products Regulatory Agency (MHRA), London, UK

• ISBN 978 0 85711 439 6
• Published Mar 2022
• Paperback
  244x172mm (1140pp)

The 2022 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, known as "The MHRA Orange Guide”, is the essential reference for all manufacturers and distributors of medicines in the UK.
It provides you with a single authoritative source of European and UK guidance, information and UK legislation relating to the manufacture and distribution of human medicines, active substances, and brokering medicines.
The new 11th edition has been updated to incorporate changes made after the UK’s exit from the European Union on the 31st January 2020.

 

Comprehensive new content includes:

• Amended extracts from the Human Medicines Regulations 2012 relating to:
• manufacture, importation and assembly
• wholesale dealing
• brokering medicine
• manufacturing, importing and distributing active substances

• The Code of Practice for Qualified Persons, Guidance on Manufacture and Importation
• UK guidance on complying with the EU guidelines on Good Distribution Practice for wholesale distributors and brokers of medicines and manufacturers, importers and distributors or active substances
• UK guidance on: risk-based inspections, conditions of holding a manufacturer’s licence, wholesale dealer’s licence, a broker registration and an active substance registration, and controls on certain medicinal products.

New guidance on:

• conditions of holding a manufacturing authorisation for investigational medicinal products,
• importing guidance for investigational medicinal products from countries on a list to Great Britain,
• Pharmaceutical Quality System expectations and Authorisation requirements for investigational medicinal products importation oversight,
• list of approved countries for import,
• pharmacovigilance for wholesalers,
• the naming of sites on a wholesale dealer’s licence,
• self-inspection for wholesale dealers and the responsible person for import.

Plus, revised GMP Annexes 2 and 17, and Commission guidance on principles and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections, for medicinal products for human use and for active substances for medicinal products for human use.
The MHRA Orange Guide is compiled by the Medicines and Healthcare products Regulatory Agency.

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• Item Code: DA9088888
• Production Capacity: 100
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CRC Press 
Published March 11, 2019 
Reference - 222 Pages - 100 B/W Illustrations

 

Summary

The Art and Science of Dermal Formulation Development is a comprehensive guide to the theory and practice of transdermal and topical formulation development, covering preclinical studies, evaluation, and regulatory approval. It enables the reader to understand the opportunities and challenges in developing products and how risks can be mitigated. Over the last 25 years, expertise in this area has declined whilst drug delivery systems for other administration routes have developed significantly. The advantages offered by transdermal and topical drug delivery remain compelling for sectors including the pharmaceutical industry, personal care, and cosmetics. This text addresses the dearth of expertise and discusses how skin can be a route of delivery and the processes in formulation development, but how such an application is very different to that used for oral, IV, and other administration routes.

 

Table of Contents

Chapter 1: Structure and Function of Human Skin.

Chapter 2: Theoretical Aspects of Transdermal and Topical Drug Delivery.

Chapter 3: Chemical Modulation of Topical and Transdermal Permeation.

Chapter 4: Physical and Technological Modulation of Topical and Transdermal Drug Delivery.

Chapter 5: Topical and Transdermal Formulation Development.;

Chapter 6: Performance Testing.

Chapter 7: Process Development Considerations for Topical and Transdermal Formulations.

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Handbook of Pharmaceutical Excipients is Jointly published by the american pharmacists association and the pharmaceutical press, publications department of the royal pharmaceutical society of great britain. written by over 140 pharmaceutical scientists from around the world, expert in the manufacture, analysis, or use of excipients. now contains 340 fully referenced excipient monographs: 40 monographs new to this edition including a number of currently used coprocessed excipients. new monographs include glycine, hydroxypropyl betadex, methionine, neotame, pentetic acid, poly(dl-lactic acid), and tagatose. 300 existing monographs completely revised and updated, and nir spectra newly added. new, improved, two-colour text design. information on the uses, and chemical and physical properties of excipients systematically collated from a variety of international sources including: pharmacopeias, patents, primary and secondary literature, websites, and manufacturers' data. extensive data provided on the applications, licensing, and safety of excipients. comprehensively cross-referenced and indexed, with many additional excipients described as related substances. an international supplier's directory and detailed information on trade names and specific grades or types of excipients commercially available. the handbook of pharmaceutical excipients is an essential resource for formulators in the pharmaceutical industry, as well as those interested in the formulation or production of confectionery, cosmetics, and food products.

Edited by raymond c rowe chief scientist, intelligensys, stokesley, north yorkshire, uk, paul j sheskey - technical services leader, the dow chemical company, midland, mi, usa  and  marian e quinn - development editor, royal pharmaceutical society of great britain, london, uk.

Contents:

• Preliminary material incl. bibliography, abbreviations and units of measurement: monographs: appendices: index:

Edited by Sandeep Nema and John D. Ludwig, Pharmaceutical Dosage Forms Parenteral Medication - 3 Vols Set related to Parenteral Medications, consists of packaging and formulation in the first volume, Processing and Sterilization in the second and Validation and Future and regulations in the third volume. The volume set was published in the year 2010 by Informa.

Features:

 

• Good print
• Excellent design
• Quality bound

Pharmaceutical Dosage Forms:Parenteral Medications, 3/E:

• Vol.1: Formulation & Packaging
• By: Sandeep Nema 
• Price: Rs.5995.00
• Pub: Informa  Year :2010 (HB)        

Pharmaceutical Dosage Forms:Parenteral Medications, 3/E:

 

• Vol. 2: Facility Design, Sterilization & Processing
• By:Sandeep Nema 
• Price: Rs.5995.00 Pub: Informa  Year :2010 (HB)       

Pharmaceutical Dosage Forms:Parenteral Medications, 3/E:

 

• Vol. 3: Regulations, Validation & the Future
• By: Sandeep Nema 
• Price: Rs.5995.00 Pub: Informa  Year :2010 (HB)  

Also available at set price Rs.14995.00 (3 Vols. Set)

 

 

The texts of the European Pharmacopoeia (Ph. Eur.) concern the qualitative and quantitative composition of medicines, the tests to be carried out on medicines, on the raw materials used in the production of medicines and on the intermediates of synthesis. It contains texts covering substances, excipients and preparations for pharmaceutical use of chemical, animal, human or herbal origin, homeopathic preparations and homeopathic stocks, antibiotics, as well as dosage forms and containers. The texts also cover biologicals, blood and plasma derivatives, vaccines and radio pharmaceutical preparations. They are legally binding.

Features:

 

• Pocket friendly prices
• High performance
• Good printout

 

Book Version: The subscription to the two initial volumes (Vol. 1 and 2) and two supplements (Supplement 7.1 and 7.2) is now available to order.

Scientific Basis for Ayurvedic Therapies reviews the latest scientific information, evaluates the research data, and presents it in an easy to use format. the editor has carefully selected topics based on the availability of scientific studies and the prevalence of a disease. with contributions from experts in their respective fields, topics include ayurvedic disease management, panchkarma, ayurvedic bhasmas, the current status of ayurveda in india, clinical research design, and evaluation of typical clinical trials of certain diseases, to name just a few.

Features covers specific disease diagnosis, etiology, pathology, management, prognosis, scientific basis for treatment reviews current scientific information major ayurvedic therapies includes information previously only found in research and journals from india explores the scientific basis of ayurvedic concepts of diseases, diagnosis, and treatments develops new interpretations of ayurvedic concepts of therapies based on modern knowledge where possible supplies a critical evaluation of published clinical and biological studies on ayurvedic therapies
summaryarguably the oldest form of health care,scientific basis for ayurvedic therapies is the first book to analyze and synthesize current research supporting ayurvedic medicine.

while there are many books devoted to ayurveda, very few have any in-depth basis in scientific studies. this book provides a critical evaluation of literature, clinical trials, and biochemical and pharmacological studies on major ayurvedic therapies that demonstrates how they are supported by scientific data. providing a natural bridge from ayurveda to western medicine, scientific basis for ayurvedic therapies facilitates the integration of these therapies by health care providers.

Table of contents :

• Preface
• Introduction
• Globalization of ayurveda, k. kurup
• Health care and disease management in ayurveda, l.c. mishra
• Clinical design and evaluation of ayurvedic therapies, b.b. singh, s.r. vinjamury, and v. singh
• Panchkarma therapy, a.k. sharma
• Immunomodulation, a. mugantiwar
• Basmas: unique ayurvedic formulas, s. raisuddin
• Diabetes, l. c. mishra and t. adra
• Thyroid dysfunction, a. kar and s. panda
• Obesity, r.a. vaidya, b.a. joshi, and n. s. nabar
• Arthritis, l. c. mishra
• Sciatica, s. singh
• Allergies, l.c. mishra
• Bronchial asthma, r. lodha
• Liver diseases and liver cancer, b. premlatha and r. govingrajan
• Antimutagenic therapies, s. kaur
• Cancer, m. sahu and l. c. mishra
• Indigestion, s. k. mitra and p.r. rangesh
• Constipation, s. k. mitra
• Hyperacidity, s. k. mitra
• Irritable bowel, s. k. mitra
• Diarrhea and dysentery, s. k. mitra
• Gastric and duodenal ülcers, k. siaram
• Cognitive disorders (alzheimers disease), d.vohora
• Epilepsy, n. kshirsagar, s. s. delvi, n.j. gotay, and h.a. bhatt
• Psychiatric disorders, r.h. singh and l. c. mishra
• Parkinson's disease, l. c. mishra and r. h. singh
• Male reproduction disorders, m. a. akbarsha and a. subramonium
• Microbial infections (krami roga), m. k. rai
• Eye diseases, a. phadke
• Ischemic heart disease, k. gautham and l.c. mishra
• Urolithiasis, i. sanjivarao
• Women's diseases, v. manjusha, n. nagashaya, s. p. vinjamury, and b.b. singh

Natural Products from Plants offers a thorough inventory of the various types of plant-derived compounds.

Features:

• Offers examples of compounds originally derived from plants for their medicinal, nutritional, and psychological value
• Brings a better understanding to natural products used for pest control; dyes and fibers; food and beverages; flavorings and fragrances; and many other novel compounds
• Contains new characterization methods using modern chromatography and spectroscopy, including one of the only available comprehensive treatments of the use of NMR spectroscopy for the characterization of natural products
• Provides new information on how plant natural products act at target sites in humans
• Includes additional resources and references for conservation of plant species and the natural areas in which they are native
• Provides indexes of plant names-common and scientific-and chemical names used in the text, in addition to the subject index

Contents:

• Phytochemicals: The Chemical Components of Plants
• How and Why These Compounds Are Synthesized by Plants
• Regulation of Metabolite Synthesis in Plants
• Plant Natural Products in the Rhizosphere
• Molecular Biology of Plant Natural Products
• The Study of Natural Product Biosynthesis in the Pregenomics and Genomics Eras
• Plant Biotechnology for the Production of Natural Products
• Traditional, Analytical, and Preparative Separations of Natural Products
• Characterization of Natural Products
• Bioassays for Activity
• Modes of Action at Target Sites
• The Uses of Plant Natural Products by Humans and Risks Associated with Their Use
• The Synergy Principle at Work with Plants, Pathogens, Insects, Herbivores, and Humans
• Plant Conservation
• Relationship Between People and Plants

The ever-growing Interest in natural product chemistry is indicated by the success of specialist journals in the field, and by the flood of natural product related papers in all the mainstream journals of organic chemistry. Chemistry of Natural Product reviews in a concise and manageable way the progress in all key areas since 1983. Very heavily referenced, the most significant advances are highlighted over a wide field of chemistry, structure, synthesis and biosynthesis. The book provides a unique entry into the vast literature on this subject for researchers and lecturers interested in natural products and synthetic organic chemistry.

Chapter 1 Carbohydrates:

• 1.1 Introduction
• 1.2 Recent developments in O-glycosidation methodology
• 1.3 Recent developments in C-glycoside synthesis
• 1.4 Synthesis of _antibiotic sugars
• 1.5 Use of carbohydrates as chiral templates and reagents for asymmetric synthesis
• 1.6 Use of carbohydrates as chiral starting materials for the synthesis of
• enantiomerically pure natural products
• References 

Chapter 2 Aromatic compounds:

 

• 2.1 Introduction
• 2.2 Benzenoids
• 2.3 Coumarins
• 2.4 Isocoumarins, chromanones, chromones and _cannabinoids
• 2.5 Macrocyclic lactones
• 2.6 Pyrones, butenolides, lignans and benzofurans
• 2.7 Terphenyls
• 2.8 Flavonoids
• 2.9 Xanthones and benzophenones
• 2.10 Naphthalenes and naphthoquinones
• 2.11 Anthraquinones
• 2.12 Anthracyclines
• 2.13 Some other Polycyclic _antibiotics
• 2.14 Ansamycins
• References

 

Pharmaceutical Process Chemistry presents detailed discussions of the published process chemistry of the ten top-selling small molecule drugs in the US in 2007, information which is usually carefully protected by the current and future manufacturers. The author identifies methodology for manufacturing these blockbuster drugs most efficiently and to highlight methodology and strategies which might be used to expedite the manufacturing of the blockbusters of the future.


Peter J. Harrington is the founder of Better Pharma Processes, LLC, a consulting firm specializing in pharmaceutical process design and development. From 1988–2008, he worked for the Syntex Technology Center, later Roche Colorado, as a research fellow. Dr. Harrington has more than fifty patents and research publications, including reviews and abstracts, as well as the book Transition Metals in Total Synthesis (Wiley).

Content:

• Chapter1: Introduction.
• Chapter2: Actos® (pioglitazone hydrochloride)
• Chapter3: Lexapro® (escitalopram oxalate)
• Chapter4: Efferox XR® (venlafaxine hydrochloride)
• Chapter5: Seroquel® (quetiapine hemifumarate)
• Chapter6: Singulair® (montelukast sodium)
• Chapter7: Prevacid® (lansoprazole)
• Chapter8: Advair Diskus® (salmeterol xinafoate)
• Chapter9: Lipitor® (atorvastatin calcium)

The now completed Second Edition of the Biotechnology 12 Volumes Set book series is the largest source of information in the field consisting of approximately 11 000 printed pages and ca. 500 contributions. Everybody involved in biotechnology will appreciate this book series at their fingertips. Clear, concise, and comprehensive Biotechnology gives scientists all the background material which is indispensable for the development of biotechnological processes. It offers a unique collection of current information on all aspects in biotechnology research and development from biological and genetic fundamentals to genomics, bioinformatics, special processes, metabolism and legal, economic and ethical dimensions. Such a huge amount of material requires easy access to the keywords, many of which are treated in different volumes. Therefore the cumulative index is a valuable and convenient tool for search throughout the whole set of volumes.


Topics included are Biological Fundamentals/ Genetic Fundamentals and Genetic Engineering/ Bioprocessing/ Measuring, Modelling, and Control/ Recombinant Proteins, Monoclonal Antibodies, and Therapeutic Genes/ Genomics and Bioinformatics/ Products of Primary Metabolism/ Products of Secondary Metabolism/ Biotransformations, Enzymes, Food, and Feed/ Special Processes/ Environmental Processes/ Legal, Economic and Ethical Dimensions/ Cumulative Index.

Table of Contents :

• Volume1: Biological Fundamentals
• Volume2: Genetic Fundamentals and Genetic EngineeringVolume 3, Bioprocessing
• Volume4: Measuring, Modelling, and Control
• Volume5a: Recombinant Proteins, Monoclonal Antibodies, and Therapeutic Genes
• Volume5b: Genomics and Bioinformatics
• Volume6: Products of Primary Metabolism
• Volume7: Products of Secondary Metabolism
• Volume8a: Bio-transformations I
• Volume9: Enzymes, Biomass, Food and Feed
• Volume10: Special Processes
• Volume11a: Environmental Processes I
• Volume11b: Environmental Processes II
• Volume11c: Environmental Processes III

The third edition of the acclaimed Manual of Industrial Microbiology and Biotechnology reviews the newest techniques, approaches, and options in the use of microorganisms and other cell culture systems for the manufacture of pharmaceuticals, industrial enzymes and proteins, foods and beverages, fuels and fine chemicals, and other products. Readers will find a rich array of methods and discussions of productive microbial processes, with means for improving the organism, the process, and the product. Cell cultures based on both prokaryotic and eukaryotic organisms are examined, including thorough coverage of mammalian cell culture. Genetics, strain improvement, genetic engineering, and bioprospecting are discussed with regard to a wide variety of organisms and processes.

Focusing on the latest advances and findings that have brought us to the current state of the art and science, this edition features an entire new section devoted to the microbial production of biofuels and fine chemicals, as well as a stronger emphasis on mammalian cell culture methods. Many chapters review the latest genomic and other “omics” approaches. The book covers new methods that enhance the capacity of microbes used for a wide range of purposes, from wine making to pharmaceuticals to bioremediation, at volumes from micro- to industrial scale.

The editors have enlisted a multidisciplinary group of experts to serve as authors, including microbial ecologists, physiologists, geneticists, biochemists, molecular biologists, and biochemical engineers. Their contributions are based not only on a thorough evaluation of the primary literature, but also on the authors’ own invaluable firsthand experience in industrial microbiology and biotechnology. Readers will find significant new insights into the development of industrial microbiology and biotechnology processes and products.

Key Features:

• Presents the state of the technology in the isolation and screening of microorganisms for the production of novel secondary metabolites and enzymes
• Sets forth genetic and molecular genetic methods to improve the production of microbial products
• Offers a broad range of methods to genetically engineer the biosynthesis of important industrial enzymes, proteins, and secondary metabolites
• Describes the latest technology for the microbial production of fuels and fine chemicals

Detail:

 

• Number of Pages: 784
• Publication Date: March 2010
• Publisher: ASM Press
• Title: Manual of Industrial Microbiology and Biotechnology, 3rd Edition

Ayurvedic Medicine brings the unique theories and traditions of Ayurveda alive so that they are accessible to the complementary health practitioner of today. Ayurvedic Medicine The Principles of Traditional Practice book offers a clear, accessible and yet detailed guide to Ayurvedic herbalism. It encompasses a brief history of the growth of Ayurveda , a discussion of its fundamental principles, treatment strategies as well as the energetic approach of traditional Ayurvedic herbal pharmacy and pharmacology. It also emphasizes the importance of using sustainably harvested herbs in clinical practice. The introductory "theoretical" chapters complement the core of the book that includes over 100 plant profiles of Ayurvedic herbs and 50 traditional formulas.

Table of Contents:

• Introduction
• History of the Ayurvedic material medica
• Ayurvedic philosophy and basic principles. Pharmacology and energetics
• Treatment
• Plant profiles
• Single herb profiles
• Formula Profiles
• Appendix
• Glossary
• Treatment Glossary
• Resources
• References
• Index

A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, Good Design Practices for GMP Pharmaceutical Facilities assists project managers as they develop, diagram, and implement pharmaceutical production facility projects-demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces.

Features:

• Spans a wide range of topics central to the successful performance of pharmaceutical oral solid, sterile product, bioprocess, active pharma ingredient, clinical material, and regulated facilities

• Contains essential background information and solutions to common challenges in the layout and formation of manufacturing facilities that must comply with current codes, statutes, and regulations in industry
• Addresses emerging trends in process technology
• Contains practical suggestions that illustrate best practices in the planning and delivery of facilities that perform and conform to current regulatory requirements and business imperatives

• Enriches decision-making by emphasizing scope development, master planning, and clear design execution

Contents:

• Pharmaceutical Industry Profile
• Current Good Manufacturing Practice
• Facility Planning. Architecture
• Mechanical/HVAC/Utilities
• High Purity Water
• Automation and Process Controls
• Validation and Facility Design
• Process Engineering
• Oral Solid Dosage Facilities
• Sterile Manufacturing Facilities
• Biotechnology Facilities
• API Facilities
• Building Code Compliance
• Containment/Isolation
• Occupational Health and Safety
• Technology Transfer
• Environmental
• Support Laboratories
• Packaging/Warehousing

Bridging the gap between US and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance comparatively presents the major substance of both the "US Current Good Manufacturing Practice for Finished Pharmaceutical Regulations" and the European "Guide to Good Manufacturing Practice for Medicinal Products".

It explores the reasoning behind the requirements and the ways and means of complying with them. Topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.

Table of Contents:

• Introduction - Status and Applicability of US Regulations/EU Guidelines - General Quality Issues
• Personnel, Organization and Training
• Premises/Buildings and Facilities
• Contamination and Contamination Control
• Equipment
• Materials Control
• Production and Process Controls
• Packaging and Labeling Control
• Holding and Distribution
• Laboratory Controls
• Records and Reports
• Returned and Salvaged Products
• Sterile Products Manufacture - Basic principles
• GMP and Quality Assurance in Sterile Products Manufacture
• Validation - General Principles
• Validation - Applications
• Self-inspection and Quality Audit
• UScGMPs and EC GMP Guide - Concluding Comparison

The first edition of Bioactive Compounds from Natural Sources was published in a period of renewed attention to biologically active compounds of natural origin. This trend has continued and intensified—natural products are again under the spotlight, in particular for their possible pharmacological applications. Largely focusing on natural products as lead compounds in drug discovery, Bioactive Compounds from Natural Sources, Second Edition: Natural Products as Lead Compounds in Drug Discovery is actually a completely new volume containing surveys of selected recent advances in an interdisciplinary area covering chemistry of natural products, medicinal chemistry, biochemistry, and other related topics.

Written by some of the most reputed scientists in the field, this second edition includes new chapters from authors who contributed to the first edition as well as many chapters compiled by new authors.

Compiled for researchers and Ph.D. students working in interdisciplinary fields, this book will also be appreciated by readers without a background in chemistry interested in bioactive natural products, their biological and pharmacological properties, and their possible use as chemopreventive or chemotherapeutic agents. Conversely, the biological and pharmacological data and methods are accessible by chemists.

Cover topic include:

• Natural sources of bioactive compounds such as aquatic cyanobacteria, filamentous fungi, and tropical plants,
• The tremendous potentiality of metabolic engineering of natural products biosynthesis
• The contribution of emerging or developing technologies to the study of bioactive natural compounds, namely computational methods and circular dichroism
• The potential of natural or natural-derived compounds for specific therapeutic applications: treatment of viral diseases, regulation of hypoxia-inducible factor, antimalarials, modulation of angiogenesis, and antitumor and wound-healing activity
• Selected examples of natural product families and related synthetic analogues, namely polyphenols and campthotecins

Table of Contents:

• Strategies and Methods for a Sustainable Search for Bioactive Compounds
• Discovery of Potential Anticancer Agents from Aquatic Cyanobacteria, Filamentous Fungi, and Tropical Plants; Metabolic Engineering of Natural Product Biosynthesis; Computational Approaches for the Discovery of Natural Lead Structures
• Recent Advances in the Application of Electronic Circular Dichroism for Studies of Bioactive Natural Products
• Natural Products as Treatments for and Leads to Active Compounds in Viral Diseases
• Natural Products as Inhibitors of Hypoxia-Inducible Factor-1 (HIF-1
• From Antitumor or Wound Healing Actions of Natural Products through Angiogenesis

This long awaited third edition of Phytochemical Methods A Guide To Modern Techniques Of Plant is, as its predecessors, a key tool for undergraduates, research workers in plant biochemistry, plant taxonomists and any researchers in related areas where the analysis of organic plant components is key to their investigations.

Phytochemistry is a rapidly expanding area with new techniques being developed and existing ones perfected and made easier to incorporate as standard methods in the laboratory. This latest edition includes descriptions of the most up-to-date methods such as HPLC and the increasingly sophisticated NMR and related spectral techniques. Other methods described are the use of NMR to locate substances within the plant cell and the chiral separation of essential oils.

After an introductory chapter on methods of plant analysis, individual chapters describe methods of identifying the different type of plant molecules: phenolic compounds, terpenoids, organic acids, lipids and related compounds, nitrogen compounds, sugar and derivatives and macromolecules. Different methods are discussed and recommended, and guidance provided for the analysis of compounds of special physiological relevance such as endogenous growth regulators, substances of pharmacological interest and screening methods for the detection of substances for taxonomic purposes. It also includes an important bibliographic guide to specialized texts.

This comprehensive book constitutes a unique and indispensable practical guide for any phytochemistry or related laboratory, and provides hands-on description of experimental techniques so that students and researchers can become familiar with these invaluable methods.

Table of contents :

• Preface
• Methods of Plant Analysis
• Phenolic Compounds
• The Terpenoids
• Organic Acids, Lipids and Related Compounds
• Nitrogen Compounds
• Sugars and their Derivatives.Macromolecules
• Appendix A: A List of Recommended TLC Systems for All Major Classes of Plant Chemical
• Appendix B: Some Useful Addresses

Uniquely, the Handbook of Pharmaceutical Excipients collects together the essential data on the physical properties of excipients as well as providing information on drug safety and potential drug toxicity, and presents this in a structured and easy-to-use format. Written concisely by leading international experts, the Handbook has become the best first drug reference point for users of excipients across many industries.

Proven worth:

 

Since its launch, drug formulators, drug manufacturers, regulatory associations and legal bodies have established it as the go-to reference work on excipients. Pharmacists and chemists have come to rely upon it as the dependable source of pharmaceutical formulation information, and in other industries such as food formulation and cosmetics formulation it has proved its worth time and time again.

 

Table of contents:

• Pharmacopoeial information from the UK, Europe, Japan and the United States where relevant
• Non-proprietary names and synonyms
• Chemical name, CAS Registry number, empirical formula, molecular weight
• Functional category, applications and incompatibilities
• Material description and typical excipient properties
• Safety, stability, storage and handling information
• Method of drug manufacture
• Related substances
• Primary references
• Editorial comments
• Author details and revision date

 

Fiedler's Encyclopedia of Excipients is founded in the year 1970, Arts of Asia is published by Arts of Asia Publications Limited. This book is published at a gap of two months i.e. 6 magazines are published annually. This is one of the largest circulated magazines in Asia covering almost 90 Countries. Supported by different institutions, organizations as well as schools and universities, this magazine is a favorite with major deals and art collectors across the globe.

Features:

 

• Good quality
• Excellent print
• Good design and layout

 

Experiments in Pharmaceutical Chemistry, Second Edition Author(s): Charles Dickson Published: February 21, 2014 by CRC Press Content: 160 Pages | 130 Illustrations
Features

• Presents an easy-to-read and user-friendly format with an introduction to each of the 22 subject areas
• Demonstrates the relevancy of topics to the field of medicinal chemistry through experiments
• Provides concise instructions for conducting laboratory investigations
• Expands the number of experiments from 54 in the previous edition to 75 in this new volume
• Includes section introductions to basic concepts underlying the field addressed and a specific bibliography relating to each field
• Requires, in most cases, only standard, inexpensive laboratory equipment
• Uses botanical materials that are available from supply houses

Summary

Written by an author with more than 40 years of teaching experience in the field, Experiments in Pharmaceutical Chemistry, Second Edition responds to a critical classroom need for material on directed laboratory investigations in biological and pharmaceutical chemistry. This new edition supplies 75 experiments, expanding the range of topics to 22 major areas of pharmaceutical chemistry. These include biochemical groups, botanical classes important to pharmacy, and major drug classifications:

• Carbohydrates
• Lipids
• Proteins
• Enzymes
• Inorganics
• Vitamins
• Steroids
• Plant Acids
• Flavonoids
• Alkaloids
• Tannins
• Resins
• Glycosides
• Gums
• Balsams
• Volatile Oils
• Analgesics
• Anesthetics
• Sulfa Drugs (Sulfonamides)
• Psychotropic Drugs
• 
  
• Nucleic Acids

Sections contain introductions to basic concepts underlying the fields addressed and a specific bibliography relating to each field. Each experiment provides detailed instructions in a user-friendly format, and can be carried out, in most cases, without the need for expensive instrumentation. This comprehensive laboratory manual offers much-needed instructional material for teaching laboratory classes in pharmaceutical chemistry. The breadth of subject matter covered provides a variety of choices for structuring a laboratory course.

 

Table of Contents

Carbohydrates

Lipids

Proteins

Enzymes

Inorganics

Vitamins

Steroids

Plant Acids

Flavonoids

Alkaloids

Tannins

Resins

Glycosides

Gums

Balsams

Volatile Oils

Analgesics

Anesthetics

Sulfa Drugs (Sulfonamides)

Psychotropic Drugs

Antibiotics

Nucleic Acids

General Bibliography

 

 

Author Bio(s)

Dr. Charles Dickson holds degrees from the University of Tampa, Wartburg Theological Seminary, Stetson University, and the University of Florida. He has retired after more than 20 years as a chemistry instructor in the nursing and pre-pharmacy program of Catawba Valley Community College in Hickory, North Carolina. During his doctoral study at the University of Florida, he held a National Institutes of Health fellowship in pharmacology. He is the author of three previous chemistry laboratory manuals, two for introductory courses and the third in medicinal chemistry. His articles in healthcare and alternative medicine have appeared in Your Health and Mother Earth News magazines, and he formerly wrote a syndicated column on these topics for the New York Times.

Product Details:

Summary

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.

 

Table of Contents

Preface

Editor

Contributors

1. Status and Applicability of U.S. Regulations: CGMP

Graham P. Bunn

2. Quality Management Systems and Risk Management

Joseph C. Near

3. Management Responsibility and Control

John E. Snyder

4. Organization and Personnel

Graham P. Bunn and Joanna B. Gallant

5. Finished Pharmaceuticals: General Provisions

Graham P. Bunn

6. Production and Process Controls

Jocelyn A. Zephrani

7. Records and Reports

Graham P. Bunn

8. Clinical Trial Supplies

David Stephon

9. Contracting and Outsourcing

Joseph C. Near

10. Buildings and Facilities

Robert Del Ciello

11. Equipment

Robert Del Ciello and Joseph T. Busfield

12. Control of Components and Drug Product Containers and Closures

Graham P. Bunn

13. Holding and Distribution

Andrew Acker

14. Returned and Salvaged Drug Products

Graham P. Bunn

15. Active Pharmaceutical Ingredients

Joseph C. Near

16. Pharmaceutical Excipient Good Manufacturing Practices

Irwin Silverstein

17. Packaging and Labeling Control

Graham P. Bunn

18. Laboratory Controls

Alex M. Hoinowski

19. Microbiological Aspects of Pharmaceutical Aseptic Processing in the Compounding Pharmacy

Dawn McIver

20. CGMP Enforcement Alternatives in the United States

Daniel G. Jarcho and Cathy L. Burgess

21. FDA Inspection Process

Cathy L. Burgess and Daniel G. Jarcho

22. FDA Pre-approval Inspections

Cathy L. Burgess, Justin Mann, and Seth Olson

23. Worldwide Good Manufacturing Practices

Dominic Parry

24. Data Integrity and Fundamental Responsibilities

Randy Hightower and Michele Pruett

Index

 

Additional Information:

• Delivery Time: Immediate

DESCRIPTIONPresents the most effective catalytic reactions in use today, with a special focus on process intensification, sustainability, waste reduction, and innovative methods 

This book demonstrates the importance of efficient catalytic transformations for producing pharmaceutically active molecules. It presents the key catalytic reactions and the most efficient catalytic processes, including their significant advantages over compared previous methods. It also places a strong emphasis on asymmetric catalytic reactions, process intensification (PI), sustainability and waste mitigation, continuous manufacturing processes as enshrined by continuous flow catalysis, and supported catalysis. 

Active Pharmaceutical Ingredients in Synthesis: Catalytic Processes in Research and Development offers chapters covering: Catalysis and Prerequisites for the Modern Pharmaceutial Industry Landscape; Catalytic Process Design - The Industrial Perspective; Hydrogenation, Hydroformylation and Other Reductions; Oxidation; ; Catalytic Addition Reactions; Catalytic Cross-Coupling Reactions; Catalytic Metathesis Reactions; Catalytic Cycloaddition Reactions: Coming Full-Circle; Catalytic Cyclopropanation Reactions; Catalytic C-H insertion Reactions; Phase Transfer Catalysis; and Biocatalysis. 

-Provides the reader with an updated clear view of the current state of the challenging field of catalysis for API production 
-Focuses on the application of catalytic methods for the synthesis of known APIs 
-Presents every key reaction, including Diels-Alder, CH Insertions, Metal-catalytic coupling-reactions, and many more 
-Includes recent patent literature for completeness 

Covering a topic of great interest for synthetic chemists and R&D researchers in the pharmaceutical industry, Active Pharmaceutical Ingredients in Synthesis: Catalytic Processes in Research and Development is a must-read for every synthetic chemist working with APIs. 
ABOUT THE AUTHOR

Anthony J. Burke, PhD, is Professor at the University of Evora, and the coordinator of the organic and organometallic research line at the Centro de Química de Evora.

Carolina S. Marques, PhD, is working as a PostDoc in the Burke group.

Nicholas J. Turner, PhD, is Professor of Chemical Biology, Director of the Centre of Excellence in Biocatalysis (CoEBio3) and co-Director of SYNBIOCHEM.

Gesine J. Hermann, PhD, is a research and business consultant for ChiraTecnics, Portugal.

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TABLE OF CONTENTS

Foreword xi

Preface xiii

Abbreviations xvii

1 Catalysis and Prerequisites for the Modern Pharmaceutical Industry Landscape 1

2 Catalytic Process Design: The Industrial Perspective 31

3 Hydrogenation, Hydroformylation, and Other Reductions 75

4 Oxidation: Nobel Prize Chemistry Catalysis 113

5 Catalytic Addition Reactions 147

6 Catalytic Cross‐Coupling Reactions – Nobel Prize Catalysis 175

7 Catalytic Metathesis Reactions: Nobel Prize Catalysis 259

8 Catalytic Cycloaddition Reactions: Coming Full Circle 291

9 Catalytic Cyclopropanation Reactions 321

10 Catalytic C–H Insertion Reactions 341

11 Phase‐Transfer Catalysis 359

12 Biocatalysis 387

References

Index

Additional Information:

• Item Code: ME0796555
• Minimum Order Quantity: 1 Piece
• Production Capacity: 2
• Delivery Time: Immediate

Stereoselective Synthesis introduce a new, simplified classification for stereoselective reactions based on changes in the number of chiral centres taking place, emphasizing the three-dimensional representations of transition states in which stereoselectivity is determined. using stereochemical vocabulary in accordance with iupac rules, it covers analysis of factors in which asymmetric induction occurs, the interplay between steric and electronic effects, the importance of conformational control, advantages of intramolecularity and the majority of important reaction types used in modern stereoselective synthesis.

Partial table of contents:

• Type0 reactions: reactions in which no new chiral centres are created.
• Typei reactions: those proceeding with either inversion or with retention of configuration at a single chiral centre, simple chirality transfer reactions: those in which a single chiral centre is transferred with concomitant migration of one or more double bonds.
• Type ii reactions: simple diastereoselectivity in 1,2-additions to alkenes, diels-alder and 1,3-dipolar cycloadditions and the ene reaction, occasional diastereoselectivity.
• Type iii reactions: those involving asymmetric induction.

Now in its 65th edition, 2011 Physicians' Desk Reference contains over 3,250 pages of labeling information on over 1,116 of the most commonly prescribed drugs, including warnings and precautions, drug interactions, contraindications as well as hundreds of full-size and full-color photographs.

Found in virtually every physician's office, pharmacy, clinic, and library, pdr is the most authoritative source of fda-regulated information on prescription drugs available! No medical reference is more current, more user-friendly, or more recognized and respected.

Pdr is completely revised and updated every year for your safety and peace of mind. For absolutely accurate information that physicians have turned to for 65 years, order your copy of the 2011 physicians' desk reference today!

This edition features:

• Comprehensive indexing (by manufacturer, brand/generic name, therapeutic category, generic/index)
• New drug information (approved in 2010)
• Color images of medications
• Complete prescribing information, including mechanism of action and pharmacokinetics, indications and contraindications, trials data, dosing side effects, warnings and precautions, and more

In today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing A CGMP Laboratory Audit System A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely on to ensure their facility remains compliant with all current and future requirements.

Focusing on a "team approach," the author uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system in order to:

• Improve current compliance
• Demonstrate sustainable compliance
• Produce data for federal inspections
• Avoid regulatory action

Table of Contents :

Preface

1.Introduction to the quality systems approach to cgmp compliance
1.1Overview of Quality Systems
1.2 Quality Systems and Compliance with CGMPs: Reasons for Auditing Your Laboratory
1.3 Goals of Auditing Your Laboratory
1.4 Laboratory Audit Phases
1.5 Integration with Existing Programs
1.6 Modifiable and Scalable Approach

Regulated Bioanalytical Laboratories provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bio analytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. the book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. finally, it guides readers through stressless internal and third party laboratory audits and inspections. it takes account to most national and international regulations and quality and accreditation standards, along with corresponding interpretation and inspection guides. the author elaborates on highly comprehensive content, making it easy not only to learn the subject but also to quickly implement the recommendations.

Table of content:

Preface acknowledgment. contributors and advisors. 1 introduction, objectives, and key requirements for glp regulations. 1.1 introduction. 1.2 objectives and key requirements for glp regulations. 1.3 fundamental understanding of glp regulations and principles. 1.4 key elements of bioanalytical methods validation. 1.5 basic principles of bioanalytical method validation and establishment. references. 2 historic perspectives of glp regulations, applicability, and relation to other regulations. 2.1 historic perspectives of glp regulations. 2.2 applicability and relations to other regulations/principles. 2.3 comparison of fda glp, epa glp regulations, and oecd glp principles. 2.4 applications of glp to multiple site studies. 2.5 21 cfr part 11 in relation to glp programs. 2.6 glp, cgmp, and iso applicabilities, similarity, and differences. 2.7 good clinical practices and good clinical laboratory practices. 2.8 gap and current initiatives on regulating laboratory analysis in support of clinical trials. references. 3 glp quality system and implementation. 3.1 glp quality system. 3.2 global glp regulations and principles. 3.3 implementation of glp regulations and oecd principles. 3.4 initiatives and implementation of bioanalytical method validation (guidance for industry bmv—may 2001). references. 4 fundamental elements and structures for regulated bioanalytical laboratories. 4.1 introduction. 4.2 fundamental elements for bioanalytical laboratories. 4.3 basic requirements for glp infrastructure and operations. 4.4 gxp quality systems references. 5 technical and regulatory aspects of bioanalytical laboratories. 6 competitiveness of bioanalytical laboratories—technical and regulatory perspectives. 7 sponsor and fda/regulatory agency glp inspections and study audits. 8 current strategies and future trends. 9 general terminologies of gxp and bioanalytical laboratories.

Characterization of Impurities and Degradants using Mass Spectrometry highlights the current practices and future trends in structural characterization of impurities and degradants. It begins with an overview of mass spectrometry techniques as related to the analysis of impurities and degradants, followed by studies involving characterization of process related impurities (including potential genotoxic impurities), and excipient related impurities in formulated products.  Both general practitioners in pharmaceutical research and specialists in analytical chemistry field will benefit from this book that will detail step-by-step approaches and new strategies to solve challenging problems related to pharmaceutical research.

Table of Contents :

Preface.
Contributors.
Acronyms.
PARTI: Ethodology.
1Introduction to Mass Spectrometry (Scott A. Smith, Ruth Waddell Smith, Yu Xia, and Zheng Ouyang).
1.1History.
1.2Ionization Methods.
1.3Mass Spectrometer Types.
1.4Tandem Mass Spectrometry.
1.5Separation Techniques Coupled to Mass Spectrometry.
1.6Prospects for Mass Spectrometry.
References:
2LC Method Development and Strategies (Gang Xue and Yining Zhao).
2.1Introduction.
2.2Column, pH and Solvent Screening.
2.3Gradient and Temperature Optimization.
2.4Orthogonal Screening.
2.5High-Efficiency Separation.
2.6Conclusions.

References.
3 Rapid Analysis of Drug-Related Substances using Desorption Electrospray Ionization and Direct Analysis in Real Time Ionization Mass Spectrometry (Hao Chen and Jiwen Li).

References.
4 Orbitrap High-Resolution Applications (Robert J. Strife).

References.
5 Structural Characterization of Impurities and Degradation Products in Pharmaceuticals Using High-Resolution LC-MS and Online Hydrogen/Deuterium Exchange Mass Spectrometry (Guodong Chen and Birendra N. Pramanik).

References.
6 Isotope Patten Recognition on Molecular Formula Determination for Structural Identification of Impurities (Ming Gu).

References.
PART II Application
7Practical Application of Very High-Pressure Liquid Chromatography Across the Pharmaceutical Development-Manufacturing Continuum (Brent Kleintop and Qinggang Wang).
References.
8 Impurity Identification for Drug Substances (David W. Berberich, Tao Jiang, Joseph McClurg, Frank Moser, and R. Randy Wilhelm).
References.
9 Impurity Identification in Process Chemistry by Mass Spectrometry (David Q. Liu, Mingjiang Sun, and Lianming Wu).
Acknowledgments.
References.
10 Structure Elucidation of Pharmaceutical Impurities and Degradants in Drug Formulation Development (Changkang Pan, Frances Liu, and Michael Motto).
Acknowledgment.
References.
11Investigation of Degradation Products and Extractables in Developing Topical OTC (Over the Counter) and NCE (New Chemical Entity) Consumer Healthcare Medication Products (Fa Zhang).
References.
12Characterization of Impurities and Degradants in Protein Therapeutics by Mass Spectrometry (Li Tao, Michael Ackerman, Wei Wu, Peiran Liu, and Reb Russell).

Cleanroom Technology providing step-by-step guidance to the design and construction of cleanrooms, appropriate testing methodologies, and operation for the minimization of contamination.

This second edition has been comprehensively revised and includes extensive updates to the two chapters that contain information on cleanroom standards and guidelines. The chapter on risk management has been extensively revised, especially the section on risk assessment. Other new subjects that have been added to the various chapters are those on clean-build, determination of air supply volumes for non-unidirectional airflow cleanrooms, RABS (Restricted Access Barrier Systems), contamination recovery test methods, entry of large items into a cleanroom, glove allergy problems, and how to develop a cleanroom cleaning programme.

Used for in-house training and a textbook in colleges, this volume is for cleanroom personnel at all levels. It provides novices with an introduction to the state-of-the-art technology and professionals with an accessible reference to the current practices. It is particularly useful in the semiconductor, pharmaceutical, biotechnology and life sciences industries.

William Whyte is an international authority in cleanrooms, with over 45 years experience in research, teaching and consulting in the electronic, healthcare and pharmaceutical industries. He is a member of British and International standards committees writing the International Cleanroom standards, and has received numerous awards for his work in Cleanroom Technology.

Table of Contents :

• About the Author
• Preface
• Acknowledgements

1 Introduction:

• 1.1 What is a Cleanroom?
• 1.2 The Need for Cleanrooms.
• 1.3 Types of Cleanrooms.
• 1.4 What is Cleanroom Technology

2 The History of Cleanrooms:

• 2.1 The Earliest Years
• 2.2 Ventilated Operating Rooms
• 2.3 Early Industrial Cleanrooms
• 2.4 Unidirectional Airflow Cleanrooms

3 Cleanroom Classification Standards:

• 3.1 The History of Standards
• 3.2 The Basis of Cleanroom Standards

5 Non-unidirectional Airflow and Ancillary Cleanrooms.
6 Unidirectional Airflow Cleanroom
7 Separative Clean Air Devices and Containment Zones
8 Construction and Clean-build
9 High Efficiency Air Filtration
10 Cleanroom Testing and Monitoring
11 Measurement of Air Quantities and Pressure Differences
12 Air Movement Control: Containment, Visualization and Recovery
13 Filter Installation Leak Testing
14 Airborne Particle Counts
15 Microbial Sampling
16 Operating a Cleanroom: Managing the Risk from Contamination.
17 Cleanroom Disciplines
18 Entry and Exit of Personnel
19 Materials, Equipment and Machinery
20 Cleanroom Clothing
21 Cleanroom Masks and Gloves
22 Cleaning a Cleanroom