Design And Analysis Of Bioavailability And Bioequivalence Studies
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Design And Analysis Of Bioavailability And Bioequivalence Studies
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2008-10-15
Design And Analysis Of Bioavailability And Bioequivalence Studies written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-10-15 with Mathematics categories.
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
Design And Analysis Of Bioavailability And Bioequivalence Studies
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 1999-11-24
Design And Analysis Of Bioavailability And Bioequivalence Studies written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-11-24 with Mathematics categories.
"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."
Design And Analysis Of Clinical Trials
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Author : Shein-Chung Chow
language : en
Publisher: Wiley-Interscience
Release Date : 1998-06-23
Design And Analysis Of Clinical Trials written by Shein-Chung Chow and has been published by Wiley-Interscience this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998-06-23 with Mathematics categories.
A unique, unifying treatment for statistics and science in clinical trials What sets this volume apart from the many books dealing with clinical trials is its integration of statistical and clinical disciplines. Stressing communication between biostatisticians and clinical scientists, this work clearly relates statistical interpretation to clinical issues arising in different stages of pharmaceutical research and development. Plus, the principles presented here are universal enough to be easily adapted in non-biopharmaceutical settings. Design and Analysis of Clinical Trials tackles concepts and methodologies. It not only covers statistical basics such as uncertainty and bias, design considerations such as patient selection, randomization, and the different types of clinical trials but also deals with various methods of data analysis, group sequential procedures for interim analysis, efficacy data evaluation, analysis of safety data, and more. Throughout, the book: * Surveys current and emerging clinical issues and newly developed statistical methods * Presents a critical review of statistical methodologies in various therapeutic areas * Features case studies from actual clinical trials * Minimizes the mathematics involved, making the material widely accessible * Offers each chapter as a self-contained entity * Includes illustrations to highlight the text This monumental reference on all facets of clinical trials is important reading for physicians, clinical and medical researchers, pharmaceutical scientists, clinical programmers, biostatisticians, and anyone involved in this burgeoning area of clinical research. It can also be used as a textbook in graduate-level courses in the field.
Generics And Bioequivalence
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Author : Andre J. Jackson
language : en
Publisher: CRC Press
Release Date : 2019-06-13
Generics And Bioequivalence written by Andre J. Jackson and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-13 with Medical categories.
Published in 1994: This text focuses on the determination of bioequivalence between formulations that are pharmaceutically equivalent and manufactured using acceptable chemistry, manufacturing and controls and in accordance with Good Manufacturing Practices.
Bioequivalence Studies In Drug Development
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Author : Dieter Hauschke
language : en
Publisher: John Wiley & Sons
Release Date : 2007-03-13
Bioequivalence Studies In Drug Development written by Dieter Hauschke and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-03-13 with Medical categories.
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.
Conduct And Analysis Of Bioavailability And Bioequivalence Studies
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Author : Canada. Health Canada
language : en
Publisher:
Release Date : 1996
Conduct And Analysis Of Bioavailability And Bioequivalence Studies written by Canada. Health Canada and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1996 with Bioavailability categories.
Drug Discovery And Evaluation Methods In Clinical Pharmacology
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Author : H.Gerhard Vogel
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-12-15
Drug Discovery And Evaluation Methods In Clinical Pharmacology written by H.Gerhard Vogel and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-15 with Medical categories.
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".
Fda Bioequivalence Standards
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Author : Lawrence X. Yu
language : en
Publisher: Springer
Release Date : 2014-09-05
Fda Bioequivalence Standards written by Lawrence X. Yu and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-09-05 with Medical categories.
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.
Pharmaceutical Medicine
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Author : Adrian Kilcoyne
language : en
Publisher: OUP Oxford
Release Date : 2013-05-23
Pharmaceutical Medicine written by Adrian Kilcoyne and has been published by OUP Oxford this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-23 with Medical categories.
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.
Topical Drug Bioavailability Bioequivalence And Penetration
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Author : Vinod P. Shah
language : en
Publisher: Springer
Release Date : 2015-01-30
Topical Drug Bioavailability Bioequivalence And Penetration written by Vinod P. Shah and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-01-30 with Medical categories.
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.