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Controversial Statistical Issues in Clinical Trials by Shein-Chung Chow
RRP: $65.78Booksplease Price: $62.54In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of... -
Statistical Design and Analysis of Stability Studies by Shein-Chung Chow
RRP: $65.78Booksplease Price: $62.54The 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 expiration dates... -
Sample Size Calculations in Clinical Research by Shein-Chung Chow
RRP: $58.04Booksplease Price: $54.88Praise for the Second Edition:"... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any... -
Adaptive Design Methods in Clinical Trials Shein-Chung Chow 9781032477602
RRP: $63.20Booksplease Price: $58.86With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed... -
Design and Analysis of Clinical Trials: Concepts and Methodologies by Shein-Chung Chow
RRP: $171.51Booksplease Price: $151.06Praise for the Second Edition: "...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite." -Journal of... -
Design and Analysis of Animal Studies in Pharmaceutical Development by Shein-Chung Chow
RRP: $65.78Booksplease Price: $62.54"Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to... -
Biosimilars: Design and Analysis of Follow-on Biologics by Shein-Chung Chow 9780367379728
RRP: $87.71Booksplease Price: $80.81As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are... -
Design and Analysis of Bioavailability and Bioequivalence Studies Shein-Chung Chow 9781032477770
RRP: $63.20Booksplease Price: $58.86Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and... -
Statistics in Drug Research: Methodologies and Recent Developments by Shein-Chung Chow 9780367396336
RRP: $87.71Booksplease Price: $80.81Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure... -
Quantitative Methods for Traditional Chinese Medicine Development by Shein-Chung Chow 9780367377380
RRP: $87.71Booksplease Price: $80.81A Western-Based Approach to Analyzing TCMsIn recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal)... -
Innovative Statistics in Regulatory Science Shein-Chung Chow (Duke Univ, USA) 9781032086538
RRP: $67.07Booksplease Price: $63.26Statistical 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 statistics. In a... -
Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability by Shein-Chung Chow
RRP: $87.71Booksplease Price: $81.84"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and... -
Analytical Similarity Assessment in Biosimilar Product Development Shein-Chung Chow (Duke Univ, USA) 9780367733834
RRP: $72.23Booksplease Price: $67.65This book focuses on analytical similarity assessment in biosimilar product development following the FDA's recommended stepwise approach for obtaining totality-of-the-evidence for approval of... -
Quantitative Methods for HIV/AIDS Research by Cliburn Chan
RRP: $64.49Booksplease Price: $59.97Quantitative Methods in HIV/AIDS Research provides a comprehensive discussion of modern statistical approaches for the analysis of HIV/AIDS data. The first section focuses on statistical issues in... -
Biosimilar Drug Product Development by Laszlo Endrenyi
RRP: $95.45Booksplease Price: $87.77When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The... -
Translational Medicine: Strategies and Statistical Methods by Dennis Cosmatos 9780367386177
RRP: $87.71Booksplease Price: $80.81Examines Critical Decisions for Transitioning Lab Science to a Clinical SettingThe development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting... -
Innovative Methods for Rare Disease Drug Development by 9780367502904
RRP: $65.78Booksplease Price: $62.15In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug products for rare... -
Handbook of Adaptive Designs in Pharmaceutical and Clinical Development Annpey Pong 9780367577117
RRP: $65.78Booksplease Price: $63.18In 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, especially during early... -
Design and Analysis of Bridging Studies by Jen-pei Liu
RRP: $65.78Booksplease Price: $62.15As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development...