Focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for... Læs mere
Written by one of the preeminent experts in the field, this book covers commonly encountered controversial statistical issues in clinical trials and,... Læs mere
The proposed book will focus on practical issues in pharmaceutical/clinical research and development from both regulatory and scientific perspectives. The book will outline and clarify those issues that have been commonly misused in the subject area of regulatory science.
Like the well-regarded and bestselling second edition, Sample Size Calculations in Clinical Research, Third Edition, presents statistical procedures for... Læs mere
Focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for... Læs mere
The proposed book will focus on practical issues in pharmaceutical/clinical research and development from both regulatory and scientific perspectives. The book will outline and clarify those issues that have been commonly misused in the subject area of regulatory science.
Innovative Methods for Rare Diseases Drug Development focuses on biostatistical applications in terms of design and analysis in pharmaceutical research and development from both regulatory and scientific (statistical) perspectives.
Offers a presentation of various activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and... Læs mere
Illustrating how stability studies play an important role in drug safety and quality assurance, this book introduces the basic concepts of stability testing. It focuses on short-term stability studies, and reviews several methods for estimating drug expiration dating periods.
Illustrating how stability studies play an important role in drug safety and quality assurance, this book introduces the basic concepts of stability... Læs mere
Taking into account the regulatory and scientific developments that have occurred since its predecessor, this third edition presents a... Læs mere