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Bioequivalence and Statistics in Clinical Pharmacology

Bioequivalence and Statistics in Clinical Pharmacology by Scott D. Patterson
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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
CRC Press; November 2005
396 pages; ISBN 9781420034936
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Title: Bioequivalence and Statistics in Clinical Pharmacology
Author: Scott D. Patterson; Byron Jones
 
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