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Biopharmaceutical books
This page provides information about recently
published books that deal with key topics in pharmaceutical drug
development.
If you would like to share information or
comments on recently published books that deal with key topics
in pharmaceutical drug development, we encourage you to post relevant
information in this discussion thread in the BioPharmNet forum.
Bioequivalence and Statistics in Clinical
Pharmacology
Scott Patterson, Byron Jones [Chapman and
Hall/CRC, 2005]
This book covers the applications and basic
elements of the theory of statistical methods in clinical pharmacology,
including the assessment of bioequivalence and describes the use
of statistics in clinical pharmacology studies of safety, ECG
monitoring, efficacy, and population pharmacokinetics.
Dose Finding in Drug Development
Naitee Ting (editor) [Springer, 2006]
This book introduces dose-finding problems
arising in the drug development process and the design and analysis
of dose-finding clinical trials.
Statistical Monitoring of Clinical Trials:
A Unified Approach
Michael A. Proschan, K.K. Gordon Lan, Janet
Turk Wittes [Springer, 2006]
This book coves key issues arising in the
design and analysis of group sequential trials.
Alex Dmitrienko, Christy Chuang-Stein, Ralph
D'Agostino (editors) [SAS Press, 2007]
The book consists of 14 chapters that describe
data analysis problems arising at various stages of drug development,
including drug discovery experiments, animal toxicology studies,
clinical pharmacology studies and Phase II and Phase III trials.
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