Introduction

The past decades have witnessed significant developments of biostatistical methodology applied to all areas of pharmaceutical drug development. These applications range from drug discovery to animal studies to Phase III trials. The use of statistical methods helps optimize a variety of drug development processes and ultimately helps ensure that new chemical entities are pure and stable, new therapies are safe and efficacious.

For the most part, new developments in biostatistical theory and applications are scattered across numerous research papers or books on specialized topics and rarely appear under the same cover. The objective of this book is to offer a broad coverage of biostatistical methodology used in drug development and ...

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