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The proposed book will focus on practical issues in pharmaceutical/clinical research and development from both regulatory and scientific perspectives....Lees meer
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability d...Lees meer
As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for appr...Lees meer
Written by one of the preeminent experts in the field, this book covers commonly encountered controversial statistical issues in clinical trials and, ...Lees meer
This second edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and c...Lees meer
Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for ea...Lees meer
Illustrating how stability studies play an important role in drug safety and quality assurance, this book introduces the basic concepts of stability t...Lees meer
Innovative Methods for Rare Diseases Drug Development focuses on biostatistical applications in terms of design and analysis in pharmaceutical researc...Lees meer
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of...Lees meer
Sample size calculation plays an important role in clinical research. It is common to observe discrepancies among study objectives, study design, stat...Lees meer