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
Focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for... Læs mere
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.
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