Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequiva
"Provides a comprehensive summary of the continuously growing literature and research activities on the regulatory requirements, scientific and practical issues, and statistical methodology of the design and analysis of bioavailability and bioequivalence studies. Includes several new chapters."
This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.
This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations. Seven comprehensive sections examine topics including in vitro drug release, topical drugs products, clinical studies, and guidelines and workshop reports, among others. The book also describes how targeted transdermal drug delivery and more sophisticated mathematical modelling can aid in understanding the bioavailability of transdermal drugs. The first edition of this book was an important reference guide for researchers working to define the effectiveness and safety of drugs and chemicals that penetrated the skin. This second edition contains cutting-edge advances in the field and is a key resource to those seeking to define the bioavailability and bioequivalence of percutaneously active compounds to improve scientific and clinical investigation and regulation.
Generics and Bioequivalence provides a clear, insightful, and in-depth analysis of the many complex issues encountered in the determination of drug bioequivalence. Included are timely updates on many controversial and newly emerging areas in the design and analysis of bioavailability and bioequivalence studies. This new reference was prepared by a group of authorities from academe, industry, and government and can be easily understood by students and experienced scientists alike. Topics presented include the role of single and multiple dosing in the determination of bioequivalence, the role of metabolites in assessing bioequivalence, stereochemical considerations in bioequivalence evaluation, uses of animal models, pharmacodynamics, and statistics. The analysis of pharmacodynamic data (especially when plasma levels are unavailable) is covered, and the nascent importance of individual bioequivalence is examined.
The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.
Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".
This book represents the invited presentations and some of the posters presented at the conference entitled "In Vitro-In Vivo Relationship (IVIVR) Workshop" held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development.
Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities. This text presents the required statistical methods, and with an outstanding practical emphasis, demonstrates their applications through numerous examples using real data from drug development. Includes all the necessary pharmacokinetic background information. Presents parametric and nonparametric statistical techniques. Describes adequate methods for power and sample size determination. Includes appropriate presentation of results from bioequivalence studies. Provides a practical overview of the design and analysis of bioequivalence studies. Presents the recent developments in methodology, including population and individual bioequivalence. Reviews the regulatory guidelines for such studies, and the existing global discrepancies. Discusses the designs and analyses of drug-drug and food-drug interaction studies. Bioequivalence Studies in Drug Development is written in an accessible style that makes it ideal for pharmaceutical scientists, clinical pharmacologists, and medical practitioners, as well as biometricians working in the pharmaceutical industry. It will also be of great value for professionals from regulatory bodies assessing bioequivalence studies.
