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Author:   Scott D. Patterson (Pfizer Vaccines Clinical Research & Development, Collegeville, Pennsylvania, USA) ,  Byron Jones
Publisher:   Taylor & Francis Ltd
Imprint:   Chapman & Hall/CRC
Volume:   15
Dimensions:   Width: 15.60cm , Height: 2.60cm , Length: 23.50cm
Weight:   0.703kg
ISBN:  

9781584885306

ISBN 10:   1584885300
Pages:   400
Publication Date:   10 November 2005
Audience:   Professional and scholarly ,  Professional & Vocational
Replaced By:   9781466585201
Format:   Hardback
Publisher's Status:   Out of Print
Availability:   Awaiting stock  

Table of Contents

DRUG DEVELOPMENT AND CLINICAL PHARMACOLOGY Aims of This Book Drug Development Clinical Pharmacology Statistics in Clinical Pharmacology Structure of the Book HISTORY AND REGULATION OF BIOEQUIVALENCE When and How BE Studies Are Performed Why Are BE Studies Performed? Deciding When Formulations Are Bioequivalent Potential Issues with TOST Bioequivalence Current International Regulation TESTING FOR AVERAGE BIOEQUIVALENCE Background Linear Model for 2 x 2 Data Applying the TOST Procedure Carry-over, Sequence, and Interaction Effects Checking Assumptions Made about the Linear Model Power and Sample Size for ABE in the 2 x 2 Design Example Where Test and Reference Are Not ABE Nonparametric Analysis Some Practical Issues BE STUDIES WITH MORE THAN TWO PERIODS Background Three-period Designs Within-subject Variability Robust Analyses for Three Period Designs Four-Period Designs Designs with More than Two Treatments Nonparametric Analyses of Tmax Technical Appendix: Efficiency Tables of Data DEALING WITH UNEXPECTED BE CHALLENGES Restricted Maximum Likelihood Modelling Failing BE and the DER Assessment Simulation Data-Based Simulation Carry-Over Optional Designs Determining Trial Size What Outliers are and How to Handle Their Data Bayesian BE Assessment Technical Appendix THE FUTURE AND RECENT PAST OF BE TESTING Brief History Individual and Population BE Scaled Average BE CLINICAL PHARMACOLOGY SAFETY STUDIES Background First-time-in-humans Sub-chronic Dosing Studies Food-Effect Assessment and DDIs Dose-Proportionality Technical Appendix QTC Background Modelling of QTc Data Interpreting the QTc Modelling Findings Design of a Thorough QTc Study in the Future Technical Appendix CLINICAL PHARMACOLOGY EFFICACY STUDIES Background Sub-chronic Dosing Phase IIa and the Proof of Concept Methodology Studies POPULATION PHARMACOKINETICS Population and Pharmacokinetics Absolute and Relative Bioavailability Age and Gender Pharmacokinetic Studies Ethnicity Liver Disease Kidney Disease Technical Appendix Epilogue Bibliography Index

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