Efficient Model-based Bioequivalence Testing
Author: Kathrin Möllenhoff
Publisher:
Published: 2019
Total Pages:
ISBN-13:
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Handbook of Bioequivalence Testing
Author: Sarfaraz K. Niazi
Publisher: CRC Press
Published: 2014-10-29
Total Pages: 1007
ISBN-13: 1482226383
DOWNLOAD EBOOKAs 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 m
Handbook of Bioequivalence Testing, Second Edition
Author: Sarfaraz K. Niazi
Publisher: CRC Press
Published: 2014-10-29
Total Pages: 1012
ISBN-13: 1482226375
DOWNLOAD EBOOKAs 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 Dissolution Testing, Bioavailability, and Bioequivalence
Author: Umesh V. Banakar
Publisher: John Wiley & Sons
Published: 2022-01-19
Total Pages: 564
ISBN-13: 1119634601
DOWNLOAD EBOOKExplore the cutting-edge of dissolution testing in an authoritative, one-stop resource In Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence: Science, Applications, and Beyond, distinguished pharmaceutical advisor and consultant Dr. Umesh Banakar delivers a comprehensive and up-to-date reference covering the established and emerging roles of dissolution testing in pharmaceutical drug development. After discussing the fundamentals of the subject, the included resources go on to explore common testing practices and methods, along with their associated challenges and issues, in the drug development life cycle. Over 19 chapters and 1100 references allow practicing scientists to fully understand the role of dissolution, apart from mere quality control. Readers will discover a wide range of topics, including automation, generic and biosimilar drug development, patents, and clinical safety. This volume offers a one-stop resource for information otherwise scattered amongst several different regulatory regimes. It also includes: A thorough introduction to the fundamentals and essential applications of pharmaceutical dissolution testing Comprehensive explorations of the foundations and drug development applications of bioavailability and bioequivalence Practical discussions about solubility, dissolution, permeability, and classification systems in drug development In-depth examinations of the mechanics of dissolution, including mathematical models and simulations An elaborate assessment of biophysiologically relevant dissolution testing and IVIVCs, and their unique applications A complete understanding of the methods, requirements, and global regulatory expectations pertaining to dissolution testing of generic drug products Ideal for drug product development and formulation scientists, quality control and assurance professionals, and regulators, Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence is also the perfect resource for intellectual property assessors.
Handbook of Bioequivalence Testing
Author: Sarfaraz K. Niazi
Publisher: CRC Press
Published: 2007-08-22
Total Pages: 602
ISBN-13: 0849383595
DOWNLOAD EBOOKAs 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
Mixed Models
Author: Eugene Demidenko
Publisher: John Wiley & Sons
Published: 2013-08-05
Total Pages: 768
ISBN-13: 1118091574
DOWNLOAD EBOOKPraise for the First Edition “This book will serve to greatly complement the growing number of texts dealing with mixed models, and I highly recommend including it in one’s personal library.” —Journal of the American Statistical Association Mixed modeling is a crucial area of statistics, enabling the analysis of clustered and longitudinal data. Mixed Models: Theory and Applications with R, Second Edition fills a gap in existing literature between mathematical and applied statistical books by presenting a powerful examination of mixed model theory and application with special attention given to the implementation in R. The new edition provides in-depth mathematical coverage of mixed models’ statistical properties and numerical algorithms, as well as nontraditional applications, such as regrowth curves, shapes, and images. The book features the latest topics in statistics including modeling of complex clustered or longitudinal data, modeling data with multiple sources of variation, modeling biological variety and heterogeneity, Healthy Akaike Information Criterion (HAIC), parameter multidimensionality, and statistics of image processing. Mixed Models: Theory and Applications with R, Second Edition features unique applications of mixed model methodology, as well as: Comprehensive theoretical discussions illustrated by examples and figures Over 300 exercises, end-of-section problems, updated data sets, and R subroutines Problems and extended projects requiring simulations in R intended to reinforce material Summaries of major results and general points of discussion at the end of each chapter Open problems in mixed modeling methodology, which can be used as the basis for research or PhD dissertations Ideal for graduate-level courses in mixed statistical modeling, the book is also an excellent reference for professionals in a range of fields, including cancer research, computer science, and engineering.
Topical Drug Bioavailability, Bioequivalence, and Penetration
Author: Vinod P. Shah
Publisher: Springer
Published: 2015-01-30
Total Pages: 393
ISBN-13: 1493912895
DOWNLOAD EBOOKThis 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.
Dermatokinetics of Therapeutic Agents
Author: S. Narasimha Murthy
Publisher: CRC Press
Published: 2011-04-15
Total Pages: 216
ISBN-13: 1439804788
DOWNLOAD EBOOKNovel drug delivery technologies strive to bypass challenging biological layers to elicit desired pharmacological activity. The skin, one of our key defensive barriers, allows certain topically applied substances and toxins to pass. The dermatokinetics of a drug determines the efficacy of treatment of skin disorders.Presenting the first compre
Testing Statistical Hypotheses of Equivalence and Noninferiority
Author: Stefan Wellek
Publisher: CRC Press
Published: 2010-06-24
Total Pages: 431
ISBN-13: 9781439808191
DOWNLOAD EBOOKWhile continuing to focus on methods of testing for two-sided equivalence, Testing Statistical Hypotheses of Equivalence and Noninferiority, Second Edition gives much more attention to noninferiority testing. It covers a spectrum of equivalence testing problems of both types, ranging from a one-sample problem with normally distributed observations
Oral Drug Absorption
Author: Jennifer B. Dressman
Publisher: CRC Press
Published: 2016-04-19
Total Pages: 432
ISBN-13: 1420077341
DOWNLOAD EBOOKOral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR an
