Drugs Discovery and Technology Books

Generic Drug Product Development, International Regulatory Requirements for Bioequivalence discusses worldwide legislative and regulatory requirements for the registration of generic and/or multi-source drug products.

An essential handbook for all professional involved in the regulation, development, and manufacture of brand-name or generic drugs, this guide provides expert advice on how to develop and market superior products while also successfully adhering to national and international laws.

Contents:

• Introduction
• Australasia
• Brazil
• Canada
• The European Union
• India
• Japan
• South Africa
• South America and Pan American Health Organization
• Taiwan
• Turkey
• The United States
• The World Health Organization

Chirality in Drug Research Eric Francotte (Editor), Wolfgang Lindner (Editor), Raimund Mannhold (Series Editor), Hugo Kubinyi (Series Editor), Gerd Folkers (Series Editor)370 pages

Description :

Divided into the three main sections of synthesis, analysis and drug development, this handbook covers all stages of the drug development process, including large-scale synthesis and purification of chirally pure pharmaceuticals.
The two editors from academia and a major pharmaceutical company have assembled an experienced, international team who provide first-hand practical advice and report previously unpublished data.

In the first section, the isolation of chiral drugs from natural sources, their production in enzymatic processes and the resolution of racemic mixtures in preparative chromatography are outlined in separate chapters. For the section on qualitative and quantitative analysis, enantioselective chromatographic methods are presented as well as optical methods and CE-MS, while the final section deals with the pharmacology, pharmacokinetics and metabolic aspects of chiral drugs, devoting whole chapters to stereoselective drug binding and modeling chiral drug-receptor interactions.
With its unique industry-relevant aspects, this is a must for medicinal and pharmaceutical chemists



Table of Contents
Introduction
Chiral drugs from a historical point of view (J. Gal)

Synthesis
Stereoselective synthesis of chiral drugs (H. Federsel)
Chiral drugs from natural source (F. Petersen)
Biotransformation methods for preparing chiral drugs and drug intermediates (M. Müller, M. Wubbolts)

Separations
Resolution of chiral drugs and drug intermediates by crystallisation (K. Saigo)
Resolution of chiral drugs by preparative chromatography (E. Francotte)

Analysis
Stereoselective chromatographic methods for drug analysis (W. Lindner)
CE-MS for the quantitative analysis of chiral drugs (J. Veuthey)
Spectrosopic methods for chiral drug analysis (N. Harada)
Modeling of chiral drug-receptor interactions (G. Folkers)


Author InformationEric Francotte received his BS and PhD degrees from the University of Louvain (Belgium). After postdoctoral work at the University of Geneva, he joined the Central Research Laboratories at Ciba-Geigy, where he was working on optically active polymers. He is now Director and Head of Separations at the Novartis Institutes for BioMedical Research in Basel (Switzerland). He is also an editor of the Wiley journal "Chirality". His major interests include development and applications of chiral stationary phases for the separation of stereoisomers on an analytical and preparative scale.

Wolfgang Lindner received his PhD degree in Organic Chemistry from the University of Graz (Austria). After several academic positions, including a period at the FDA in Bethesda (USA), he was appointed the chair in Analytical Chemistry at the University of Vienna (Austria). He is also the editor of the Journal of Chromatography B, and the current president of the Austrian Society of Analytical Chemistry. His major interests lie in enantioselective separation techniques, including LC, CE, membranes, extractions and in stereoselective pharmacokinetics.

Drug-Drug Interactions in Pharmaceutical Development
Albert P. Li (Editor),     Binghe Wang
244 pages


Description :

Drug-Drug Interactions in Pharmaceutical Development comprehensively reviews the relevant science, industrial practice, and regulatory agency positions on drug-drug interactions. It focuses on the evaluation of potential drug-drug interactions, allowing researchers to address risk factors before a drug is put to market. The book covers both clinical and nonclinical aspects for understanding drug-drug interactions as well as in vitro and in vivo studies for use in studying interactions at the drug discovery stage.

Contents

 

1. In Vitro evaluation of metabolic drug-drug interactions: concepts and practice
2. In Vitro approaches to anticipating clinical drug interactions
3. Inhibition of drug-metabolizing enzymes and drug-drug interactions in drug discovery and development
4. Mechanism-based CYP inhibition: enzyme kinetics, assays, and prediction of human drug-drug interactions
5. Genomic approaches to drug-drug interactions
6. Transporters and drug interactions
7. Transporter-mediated drug interactions: molecular mechanisms and clinical implications
8. Recent case studies of clinically significant drug-drug interactions and the limits of In Vitro prediction methodology
9. U.S. regulatory perspective: drug-drug interactions
10. Herbal drug interactionsa Canadian perspective

Index

Guidebook for Drug Regulatory Submissions
By Sandy Weinberg
379 pages,   March 2009



Description :

Destined to become every regulatory director's essential desktop companion

rofessionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.

Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines.

As well, vital information is provided on the most common types of submissions, including:

 

• Meeting Requests

• Orphan Drug Applications

• Investigatory New Drug Applications (INDAs)

• New Drug Applications (NDAs)

• 505(b)2 NDAs

• Abbreviated New Drug Applications (ANDAs)

• Annual Report

This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia.

Guidebook for Drug Regulatory Submissions is more than a useful guide—it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.

Table of ContentsChapter 1. Ten Rules for Drug Regulatory Submissions.

Chapter 2. FDA Meeting Requests.

Chapter 3. Orphan Drug Applications.

Chapter 4. Investigatory New Drug Applications (INDs).

Chapter 5. New Drug Applications (NDAs).

Chapter 6. 505(b)2 New Drug Applications.

Chapter 7. Abbreviated New Drug Applications (ANDAs).

Chapter 8. Annual Reports.

Chapter 9. International Submissions (Carl A. Rockburne).

Chapter 10. Future Issues in Regulatory Submissions.

Author Information

SANDY WEINBERG is the former Vice President for Regulatory Affairs and Quality Assurance at Tikvah Therapeutics, Inc., and is now Associate Professor of Health Care Management and Director of the Master in Health Administration Graduate Program at Clayton State University in Atlanta. He has thirty years of experience in the field of drug regulatory affairs and is the author of twelve books, most recently Good Laboratory Practice Regulations, Fourth Edition.

Martindale
The Complete Drug Reference
37th edition
2-Volume Set +
Online Package

edited by
Sean C. Sweetman

 

Martindale's Complete Drug Reference is the foremost source for medicines information worldwide and also includes details on herbal medicines.

When you purchase this new two-volume set, 37th edition, you will receive the full book and digital package, consisting of the two volume reference book in a sturdy slip case, plus one year's individual access to the online version of Martindale via MedicinesComplete, with all the attendant benefits, including updating every 90 days. Purchasers will have the opportunity to renew their online access at substantially discounted rates.

Martindale's Complete Drug Reference provides reliable, unbiased and independently evaluated information on drugs and medicines used throughout the world—no other source has this breadth and depth of coverage. It is a comprehensive source of information on drugs and other substances of interest to pharmacists and medical practitioners.

In addition to encyclopedic information on drugs used clinically, it also includes veterinary and investigational drugs, other compounds used in medicine, pharmaceutical excipients, herbal medicines, toxic substances, and more.

Martindale The Complete Drug Reference 37th edition provides reliable, unbiased and evaluated information on drugs and medicines used throughout the world—no other source has the breadth and depth of coverage.

 

• Encyclopaedic facts about drugs and medicines
• 5,930 drug monographs
• 161,700 preparations
• 54,500 reference citations
• 15,300 manufacturers
• Synopses of disease treatments
• Enables identification of medicines, the local equivalent and the manufacturer
• Includes herbals, diagnostic agents, radiopharmaceuticals, pharmaceutical excipients, toxins, and poisons as well as drugs and medicines
• Based on published information and extensively referenced

New for the 37th edition:

• Over 240 new monographs
• Chapters reorganized to improve the usefulness of the book
• Increase in synonyms from Russia
• Herbal ATC codes added
• FDA UNII codes added
• Coverage of proprietary preparations expanded to 41 countries and regions, now including Ukraine

 

New Drug
Approval Process
Global Challenges and Solutions
Fifth edition

Edited by Richard A. Guarino

The thoroughly revised Fifth edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.

Updated chapters include:

• Advances in international regulatory requirements, including ICH guidelines and harmonization
• A step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs
• The latest regulatory requirements for expediting new drug approvals
• Strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development
• And more

Contents

Part I: Administartive Guidelines for New Product Development

 

1. Drug Development Teams
2. FDA Approvable Indications and Other Considerations
3. Data Presentation for Global Submissions: Text and Tabular ExpositionCTD Format
4. Technology ChangeEnabling Clinical Research and Drug Development Processesk
5. Working with a Contract Research Organization (CRO)
6. Industry and FDA Liaison

Part II: Global Regulatory Submission of Drugs, Biologics and Devices for New Product Approval

 

1. Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology
2. The Investigational New Drug Application (IND), the Investigational Medicinal Product Dossier (IMPD) and the Investigators Brochure (IB)
3. New Product Applications for Global Pharmaceutical Product Approvals: U.S. NDA Vs. Global CTD Formats
4. Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs)
5. The CTD and eCTD for the Registration of Pharmaceuticals for Human Use
6. The Biologic License Application
7. Chemistry, Manufacturing, and Control (ICH Quality Guidelines)
8. New Medical Device Approval Process in the United States
9. Orphan Drugs

Part III: Developing Clinical Research Trials

 

1. Clinical Research Protocols
2. Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Research Subjects in the U.S. and Foreign Clinical Trials
3. HIPAA: A New Requirement to the Clinical Study Process
4. Adverse Events and Reactions: Etiology, Drug Interactions, Collection, and Reporting
5. Biostatistics in Pharmaceutical Product Development Facts, Recommendations, and Solutions

Part IV: Global Regulations for Good Clinical Practices (GCP)

 

1. CFR/ICH/EU GCP Obligations of Investigators, Sponsors, and Monitors
2. Quality Assurance
3. Managing and Monitoring Clinical Trials
4. European CT Directive: Implementation and Update

Part V: Specific Areas of New Product Submissions

 

1. Combination Products
2. The Current State of GXP in China

Acronyms and Initialisms
Index

Martindale: The Complete Drug Reference Brayfield, Alison

 

Thirty-eighth edition

 

Published Jun 2014

Hardback, 2 volumes
276 x 219mm (4688pp)

 

Martindale: The Complete Drug Reference provides reliable, unbiased and evaluated information on drugs and medicines used throughout the world. Based on published information and extensively referenced, Martindale develops as the body of knowledge on existing drugs grows. The most clinically relevant and appropriate information is evaluated and selected from reliable published sources.

Unique Benefits:

• Breadth: No other source has breadth of coverage or level of detail making it the ideal firstline reference work as well as a trusted source of information for more detailed drug enquiries
• Global coverage: Martindale is the leading resource in terms of international coverage – alternative publications have a narrow regional focus
• Objectivity: Respected for the accuracy of content and independence from pharmaceutical industry. Based on published information and extensively referenced
• International adoption: Recognised and adopted worldwide

This package contains two hardback volumes presented in a slipcase with:

• Over 6,000 (and over 7,000 online) drug monographs
• Over 180,000 (and over 240,000 online) preparations
• Over 54,000 reference citations
• About 20,000 (and 25,000 online) manufacturers and distributors
• Proprietary preparations from 43 countries and regions
• Nearly 700 disease reviews, with references from the published literature
• Information to enable identification of medicines, the local equivalent and the manufacturer
• Herbals, diagnostic agents, radiopharmaceuticals, pharmaceutical excipients, toxins, and poisons as well as drugs and medicines.

 

Improvements to the 38th edition of Martindale include:

• Pages completely redesigned to improve readability
• Layout of the monographs restructured with greater prominence to uses and administration
• Over 200 new monographs
• Increased coverage of proprietary preparations – now covers 43 countries and regions, including China
• Porphyria abstracts extensively revised

A Practical Guide to Assay Development and High-Throughput Screening in Drug Discovery Author(s): Taosheng Chen 291 Pages | 83 Illustrations Features

•  
  • Integrates the knowledge of experts in biology, chemistry, informatics, instrumentation, automation, technology development, and project management

•  
  • Enables researchers in industrial and academic settings to find the most efficient way to carry a project from start to finish

•  
  • Identifies critical targets that are of relevance to drug discovery

•  
  • Discusses the components of the HTS process and provides step-by-step instructions

•  
  • Examines emerging technologies and systems

 

Summary 

The development of suitable assays, the integration of appropriate technology, and the effective management of the essential infrastructure are all critical to the success of any high-throughput screening (HTS) endeavor. However, few scientists have the multidisciplinary experience needed to control all aspects of an HTS drug discovery project. A Practical Guide to Assay Development and High-Throughput Screening in Drug Discovery integrates the experience of diverse experts who offer fundamental and practical guidance across numerous situations. 

The book first discusses assay developments for important target classes such as protein kinases and phosphatases, proteases, nuclear receptors, G protein-coupled receptors, ion channels, and heat shock proteins. It next examines assay developments for cell viability, apoptosis, and infectious diseases. The contributors explore the application of emerging technologies and systems, including image-based high content screening, RNA interference, and primary cells. Finally, they discuss the essential components of the integrated HTS process, such as screening automation, compound library management, the screening of natural products from botanical sources, and screening informatics.

 

Designed to motivate researchers to bring further advances to the field, this volume provides practical guidance on how to initiate, validate, optimize, and manage a bioassay intended to screen large collections of compounds. Drawing on the knowledge from experts actively involved in assay development and HTS, this is a resource that is both comprehensive and focused.

 

Table of Contents

 

Assay Development for Protein Kinases and Phosphatases, J. F. Glickman

Fluorescence-Based Biochemical Protease Assay Formats, J. Woelcke and U. Hassiepen 

Assay Development for Nuclear Hormone Receptors, C. Bai and E. N. Johnson

Assay Development for G Protein-Coupled Receptors and Ion Channels, J. G. McGivern, Y. Qian, and P. H. Lee 

Assay Development for Heat Shock Proteins, Z. Gao and S. Fong

Assay Development for Cell Viability and Apoptosis for High Throughput Screening, T. L. Riss, R. A. Moravec, and A. L. Niles 

Assay Development for Antimicrobial Drug Discovery, H. H. Xu

Image-Based High Content Screening, Y. Feng and C. J. Wilson 

Application of RNA Interference in Drug Discovery, N. M. Wolters and J. P. MacKeigan

Assay Development Using Primary and Primary-Like Cells, S. Corazza and E. J. Wade 

Screening Automation, W. Zheng and C. Z. Chen

Compound Library Management, D. Nie 

Unique Discovery Aspects of Utilizing Botanical Sources, S. P. Manly, T. Smillie, J. P. Hester, I. Khan, and L. Coudurier

Screening Informatics, S. C. Schürer and N. F. Tsinoremas 

Index

Coloring of Food, Drugs and Cosmetics

By Gisbert Otterstätter

This versatile guide provides a wide range of information on the composition, utilization, and evaluation of colorants and pigments in food, pharmaceuticals, and cosmetic products.

Tabulates key data for food, drug, and cosmetic colorants by Color Index Number!

Thoroughly describing the relationships between coloring reactions, Coloring of Food, Drugs and Cosmetics

• Presents the basic approval requirements for coloring materials
• Discusses the identification and practical implementation of colorants
• Features simple analytical methods and quality assurance techniques
• Reviews the current certification status of a large array of colorants
• Shows which colorants can be used in specific products
• Includes helpful references to the literature for further research
• And more!

With over 300 tables and drawings, Coloring of Food, Drugs and Cosmetics is suitable for food scientists and technologists; food, cosmetics, pharmaceutical, chemical, agricultural, and biochemical engineers; pharmacists; quality control and assurance managers; biochemists and biotechnologists; and upper-level undergraduate and graduate students in these disciplines.

Contents

1. Basic Definitions
2. Food Coloration
3. Drug Coloration
4. The Coloration of Cosmetic Products
5. The Coloration of Food, Drugs and Cosmetics in the Public Discussion
6. Product Development
7. Safety and Quality
8. Analysis
9. Data Sheets of Colorants for Food, Drugs, and Cosmetics

Glossary