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Statistical Design and Analysis of Stability Studies
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 data did not support existing …
Quantitative Methods for Traditional Chinese Medicine Development
A Western-Based Approach to Analyzing TCMsIn recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional …
Innovative Statistics in Regulatory Science
Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory …
Adaptive Design Methods in Clinical Trials
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA’s recent draft guidance, a new edition of one of the first books on the …
Translational Medicine
Examines Critical Decisions for Transitioning Lab Science to a Clinical SettingThe development of therapeutic pharmaceutical compounds is becoming more expensive, and the success …
Methodologies in Biosimilar Product Development
Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a …
Biosimilars
As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug …
Design and Analysis of Bioavailability and Bioequivalence Studies
Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of …
Statistical Design and Analysis in Pharmaceutical Science
"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical …
Sample Size Calculations in Clinical Research
Praise for the Second Edition:"… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae …
Statistics in Drug Research
Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical …
Handbook of Adaptive Designs in Pharmaceutical and Clinical Development
In response to the US FDA’s Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, …