Taking into account the regulatory and scientific developments that have occurred since its predecessor, this third edition presents a comprehensive summary of the ever-expanding literature and research in the field. It focuses on regulatory requirements, current scientific and practical issues, and the statistical methodology of designing and analyzing bioequivalence studies. It contains four new chapters, along with several new and updated sections. This edition includes guidelines issued by the FDA, EMEA, and WHO, ...
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Taking into account the regulatory and scientific developments that have occurred since its predecessor, this third edition presents a comprehensive summary of the ever-expanding literature and research in the field. It focuses on regulatory requirements, current scientific and practical issues, and the statistical methodology of designing and analyzing bioequivalence studies. It contains four new chapters, along with several new and updated sections. This edition includes guidelines issued by the FDA, EMEA, and WHO, addresses frequently asked questions, and explores the key topics of sample size determination, meta-analysis, and pharmacokinetics.
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