Shein-Chung (Duke Univ Chow Forfatter
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Analytical Similarity Assessment in Biosimilar Product Development (Bog, Hardback, Engelsk)
Focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for... Læs mere
Levering: Skaffevare (forvent 14 - 30 hverdage) -
Innovative Statistics in Regulatory Science (Bog, Hardback, Engelsk)
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.
Levering: Skaffevare (forvent 14 - 30 hverdage) -
Sample Size Calculations in Clinical Research (Bog, Hardback, Engelsk)
Like the well-regarded and bestselling second edition, Sample Size Calculations in Clinical Research, Third Edition, presents statistical procedures for... Læs mere
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Design and Analysis of Bioavailability and Bioequivalence Studies (Bog, Hardback, Engelsk)
Offers a presentation of various activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and... Læs mere
Levering: Skaffevare (forvent 14 - 30 hverdage) -
Controversial Statistical Issues in Clinical Trials (Bog, Hardback, Engelsk)Levering: Skaffevare (forvent 14 - 30 hverdage)
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Statistical Design and Analysis of Stability Studies (Bog, Hardback, Engelsk)
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.
Levering: Skaffevare (forvent 14 - 30 hverdage)
