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Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edit...
"Provides a comprehensive summary of the continuously growing literature and research activities on the regulatory requirements, scientific and practi...
Concepts and Methodologies
Praise for the Second Edition: “...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with ...
Presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. Emphasizes r...
Validation, Process Controls, and Stability
"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing...
This monumental reference on all facets of clinical trials provides comprehensive coverage and emphasis on clearly stated and defined concepts, method...
Taking into account the International Conference Harmonisation E5 framework for bridging studies, this book covers the regulatory requirements, scient...