Bioequivalence Studies In Drug Development

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Bioequivalence Studies in Drug Development

Author : Dieter Hauschke
Publisher : John Wiley & Sons
ISBN 13 : 0470094761
Total Pages : 328 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis Bioequivalence Studies in Drug Development by : Dieter Hauschke

Download or read book Bioequivalence Studies in Drug Development written by Dieter Hauschke and published by John Wiley & Sons. This book was released on 2007-03-13 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Bioequivalence Studies in Drug Development

Author : Dieter Hauschke
Publisher : Wiley
ISBN 13 : 9780470094754
Total Pages : 328 pages
Book Rating : 4.0/5 (947 download)

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Book Synopsis Bioequivalence Studies in Drug Development by : Dieter Hauschke

Download or read book Bioequivalence Studies in Drug Development written by Dieter Hauschke and published by Wiley. This book was released on 2007-02-27 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Bioequivalence and Statistics in Clinical Pharmacology

Author : Scott D. Patterson
Publisher : CRC Press
ISBN 13 : 1466585218
Total Pages : 434 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Bioequivalence and Statistics in Clinical Pharmacology by : Scott D. Patterson

Download or read book Bioequivalence and Statistics in Clinical Pharmacology written by Scott D. Patterson and published by CRC Press. This book was released on 2017-03-27 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials. This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.

Handbook of Bioequivalence Testing

Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 0849383595
Total Pages : 602 pages
Book Rating : 4.8/5 (493 download)

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Book Synopsis Handbook of Bioequivalence Testing by : Sarfaraz K. Niazi

Download or read book Handbook of Bioequivalence Testing written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2007-08-22 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made

Generic Drug Product Development

Author : Isadore Kanfer
Publisher : CRC Press
ISBN 13 : 1420020021
Total Pages : 334 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Generic Drug Product Development by : Isadore Kanfer

Download or read book Generic Drug Product Development written by Isadore Kanfer and published by CRC Press. This book was released on 2016-04-19 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica

Applied Biopharmaceutics and Pharmacokinetics

Author : Leon Shargel
Publisher : McGraw-Hill/Appleton & Lange
ISBN 13 : 9780838502396
Total Pages : 625 pages
Book Rating : 4.5/5 (23 download)

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Book Synopsis Applied Biopharmaceutics and Pharmacokinetics by : Leon Shargel

Download or read book Applied Biopharmaceutics and Pharmacokinetics written by Leon Shargel and published by McGraw-Hill/Appleton & Lange. This book was released on 1993 with total page 625 pages. Available in PDF, EPUB and Kindle. Book excerpt:

FDA Bioequivalence Standards

Author : Lawrence X. Yu
Publisher : Springer
ISBN 13 : 1493912526
Total Pages : 472 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis FDA Bioequivalence Standards by : Lawrence X. Yu

Download or read book FDA Bioequivalence Standards written by Lawrence X. Yu and published by Springer. This book was released on 2014-09-05 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Statistical Issues in Drug Development

Author : Stephen S. Senn
Publisher : John Wiley & Sons
ISBN 13 : 9780470723579
Total Pages : 523 pages
Book Rating : 4.7/5 (235 download)

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Book Synopsis Statistical Issues in Drug Development by : Stephen S. Senn

Download or read book Statistical Issues in Drug Development written by Stephen S. Senn and published by John Wiley & Sons. This book was released on 2008-02-28 with total page 523 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and interpretation ofclinical trials. Expanded sections on missing data, equivalence, meta-analysisand dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage ofpharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9,Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue betweenstatisticians and life scientists working within the pharmaceuticalindustry. The accessible and wide-ranging coverage make itessential reading for both statisticians and non-statisticiansworking in the pharmaceutical industry, regulatory bodies andmedical research institutes. There is also much to benefitundergraduate and postgraduate students whose courses include amedical statistics component.

Concepts and Strategies in New Drug Development

Author : Peter U. Nwangwu
Publisher : Greenwood
ISBN 13 :
Total Pages : 300 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Concepts and Strategies in New Drug Development by : Peter U. Nwangwu

Download or read book Concepts and Strategies in New Drug Development written by Peter U. Nwangwu and published by Greenwood. This book was released on 1983 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Biopharmaceutics Applications in Drug Development

Author : Rajesh Krishna
Publisher : Springer Science & Business Media
ISBN 13 : 038772379X
Total Pages : 416 pages
Book Rating : 4.3/5 (877 download)

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Book Synopsis Biopharmaceutics Applications in Drug Development by : Rajesh Krishna

Download or read book Biopharmaceutics Applications in Drug Development written by Rajesh Krishna and published by Springer Science & Business Media. This book was released on 2007-09-20 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.

Pharmacokinetics and Pharmacodynamics of Biotech Drugs

Author : Bernd Meibohm
Publisher : John Wiley & Sons
ISBN 13 : 3527609520
Total Pages : 426 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Pharmacokinetics and Pharmacodynamics of Biotech Drugs by : Bernd Meibohm

Download or read book Pharmacokinetics and Pharmacodynamics of Biotech Drugs written by Bernd Meibohm and published by John Wiley & Sons. This book was released on 2006-12-13 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: This first ever coverage of the pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals meets the need for a comprehensive book in this field. It spans all topics from lead identification right up to final-stage clinical trials. Following an introduction to the role of PK and PD in the development of biotech drugs, the book goes on to cover the basics, including the pharmacokinetics of peptides, monoclonal antibodies, antisense oligonucleotides, as well as viral and non-viral gene delivery vectors. The second section discusses such challenges and opportunities as pulmonary delivery of proteins and peptides, and the delivery of oligonucleotides. The final section considers the integration of PK and PD concepts into the biotech drug development plan, taking as case studies the preclinical and clinical drug development of tasidotin, as well as the examples of cetuximab and pegfilgrastim. The result is vital reading for all pharmaceutical researchers.

Bioequivalence Requirements in Various Global Jurisdictions

Author : Isadore Kanfer
Publisher : Springer
ISBN 13 : 3319680781
Total Pages : 345 pages
Book Rating : 4.3/5 (196 download)

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Book Synopsis Bioequivalence Requirements in Various Global Jurisdictions by : Isadore Kanfer

Download or read book Bioequivalence Requirements in Various Global Jurisdictions written by Isadore Kanfer and published by Springer. This book was released on 2017-12-05 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.

Pharmacokinetics in Drug Development

Author : Peter L. Bonate
Publisher : Springer Science & Business Media
ISBN 13 : 9780971176737
Total Pages : 516 pages
Book Rating : 4.1/5 (767 download)

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Book Synopsis Pharmacokinetics in Drug Development by : Peter L. Bonate

Download or read book Pharmacokinetics in Drug Development written by Peter L. Bonate and published by Springer Science & Business Media. This book was released on 2005-12-05 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt: These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. The volumes fill a gap between the academic science and the practical application of that knowledge in drug development. Volume 1 discusses the role that PK plays in selected clinical study designs. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.

Generic Drug Product Development

Author : Isadore Kanfer
Publisher : CRC Press
ISBN 13 : 1420020013
Total Pages : 287 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Generic Drug Product Development by : Isadore Kanfer

Download or read book Generic Drug Product Development written by Isadore Kanfer and published by CRC Press. This book was released on 2007-11-15 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important comp

Handbook of Bioequivalence Testing, Second Edition

Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1482226375
Total Pages : 1012 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Handbook of Bioequivalence Testing, Second Edition by : Sarfaraz K. Niazi

Download or read book Handbook of Bioequivalence Testing, Second Edition written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2014-10-29 with total page 1012 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements. New topics include: A historical perspective on generic pharmaceuticals New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications Models of noninferiority Biosimilarity of large molecule drugs Bioequivalence of complementary and alternate medicines Bioequivalence of biosimilar therapeutic proteins and monoclonal antibodies New FDA guidelines for bioanalytical method validation Outsourcing and monitoring of bioequivalence studies The cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval—including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs—allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.

Pharmaceutical Formulation Design

Author : Usama Ahmad
Publisher : BoD – Books on Demand
ISBN 13 : 1789856620
Total Pages : 166 pages
Book Rating : 4.7/5 (898 download)

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Book Synopsis Pharmaceutical Formulation Design by : Usama Ahmad

Download or read book Pharmaceutical Formulation Design written by Usama Ahmad and published by BoD – Books on Demand. This book was released on 2020-02-05 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical formulations have evolved from simple and traditional systems to more modern and complex novel dosage forms. Formulation development is a tedious process and requires an enormous amount of effort from many different people. Developing a stable novel dosage form and further targeting it to the desired site inside the body has always been a challenge. The purpose of this book is to bring together scholarly articles that highlight recent developments and trends in pharmaceutical formulation science. Each article has been written by authors specializing in the subject area and hailing from top institutions around the world. The book has been written in a systematic and lucid style explaining all basic concepts and fundamentals in a very simple way. This book aims to serve the need of all individuals involved at any level in the pharmaceutical dosage form development. I sincerely hope that the book will be liked by inquisitive students and learned colleagues.

Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition

Author : Allen Cato
Publisher : CRC Press
ISBN 13 : 0824744802
Total Pages : 451 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition by : Allen Cato

Download or read book Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition written by Allen Cato and published by CRC Press. This book was released on 2002-03-26 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.