This book reviews the history, regulatory status, pharmacopeial specifications, and harmonization of pharmaceutical excipients in the United States and Europe, and provides a comprehensive understanding of the current scientific basis for safety evaluation and risk assessment.
Examines excipients as a unique class of products and explores new procedures for determining toxicity!
A timely and unique addition to the pharmaceutical literature, containing over 570 citations that support and enhance the text, Excipient Toxicity and Safety
Excipient Toxicity and Safety is a blue-ribbon reference ideal for pharmacists; toxicologists; pharmacologists; analytical chemists; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.
Active Pharmaceutical Ingredients, Second edition is a comprehensive guide to the development, manufacturing, and regulation of the preparation and use of Active Pharmaceutical Ingredients (APIs) globally.
This new edition brings you up-to-date with the quality control regulations for APIs that have been added or amended since the first edition was published in 2005. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.
New features include:
Biotechnology of Antibiotics
edited by William R. Strohl
This incomparable Second Edition of a highly regarded reference has been entirely rewritten and enlarged to reflect the explosion of information and technologies that have emerged since the publication of the previous edition.
Strikes the perfect balance between proven traditional approaches and modern methods that promise to yield new products and processes!
Specifically addressing microbially derived commercially important bioactive products that are currently or soon-to-be available, Biotechnology of Antibiotics, Second Edition:
Written by authorities from both industry and academia and containing nearly 4000 bibliographic citations, Biotechnology of Antibiotics, Second Edition is an outstanding resource for pharmaceutical scientists, medicinal chemists and biochemists, molecular biologists and industrial microbiologists, chemical engineers, fermentation bioengineers, bioprocess technologists, and upper-level undergraduate and graduate students in these disciplines.
Whether preparing for regulatory submissions or preapproval, investigator-directed, routin, or foreign inspection, this reference is assured to enhance the facility- and compliance-readiness of any company requiring a strengthened approach to compliance and total quality management.
Providing innovative programs for every key quality system within an FDA environment, this guide evaluates critical compliance and quality challenges within the context of FDA expectations, current industry standards, and emerging global trends.
Dermal Absorption and Toxicity Assessment supplies a state-of-the-art overview of the dermal absorption process.
Skin Barrier Properties and Absorption
Modeling of Dermal Absorption and Risk Assessment
Skin Toxicity and Prevention
Specific Examples of Absorption
Contains current American Association of Pharmaceutical Scientists/Food and Drug Administration (AAPS/FDA) guidelines for the experimentation and analysis of in vivo and in vitro percutaneous absorption!
This up-to-the-minute reference provides comprehensive coverage of the latest advances in the development, preparation, and application of topical and transdermal therapeutic systems—exploring the biochemistry and treatment of various skin diseases as well as the structure and function of the skin, adverse dermal responses to drug formulations, mechanisms of drug transport through barrier membranes, and methods for measuring and modulating percutaneous permeation.
Offers contemporary discussions on the bioequivalence of dermatological and transdermal dosage forms!
Dermatological and Transdermal Formulations covers:
With more than 1800 useful references and 350 illustrations, tables, and equations, Dermatological and Transdermal Formulations is an essential source for cosmetic and pharmaceutical scientists, dermatologists, toxicologists, agrochemists, regulatory agency personnel, and upper-level undergraduate and graduate students in these disciplines.
Dose Optimization in Drug Development provides a concise overview of the key principles in dose selection and optimization and demonstrates applicability to recent successful new drug applications.
Drug Delivery Nanoparticles Formulation and Characterization presents key aspects of nanoparticulate system development for various therapeutic applications and provides advanced methods used to file for regulatory approval.
This comprehensive guide features:
Drug Delivery to the Oral Cavity emphasizes the impact of intraoral drug delivery and its advantages over conventional oral dosage forms.
Drug Targeting Technology:
Physical • Chemical • Biological Methods
edited by Hans Schreier
Drug Targeting Technology discusses physical, chemical, and biological approaches to drug targeting technology, focusing on oral, dispersed system, topical, dermal, transdermal, and inhalation delivery, and the development of original formulations that are matched by innovative device design.
Considers the efforts in biotechnology and molecular biology to produce intelligent drug delivery devices by exploiting biological pathways!
Containing over 1100 references to facilitate further study, Drug Targeting Technology:
Suggesting harnessing biological processes as the ultimate approach to the delivery or expression of pharmacologically active agents, Drug Targeting Technology is a top-shelf reference for pharmacists, pharmacologists, and pharmaceutical scientists; analytical, surface, physical, and colloid chemists and biochemists; and upper-level undergraduate and graduate students in these disciplines.
Rapid advances in the science of granulation, particle engineering and process controls, along with regulatory changes, have prompted key opinion leaders and regulatory authorities to develop the Third Edition of this authoritative, practical reference book.
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