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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, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the principles and latest statistical methodologies used when modifying trial procedures based on accrued data of ongoing clinical trials. The book also gives a well-balanced summary of current regulatory perspectives.

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As 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 process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol.

Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores ethnic sensitivity, the...

Like the well-regarded and bestselling second edition, Sample Size Calculations in Clinical Research, Third Edition, presents statistical procedures for performing sample size calculations during various phases of clinical research and development. This new edition will be updated throughout and will contain four entirely new chapters written especially for this edition.

When a biological drug patent expires, alternative biosimilar products are developed. Biological drugs are different in many respects from drugs based on chemically synthesized small molecules. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is complicated and difficult. This book presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and post-approval issues.

This is the first study of monstrosity in Jewish history from the Middle Ages to modernity. Drawing on Jewish history, literary studies, folklore, art history and the history of science, it examines both the historical depiction of Jews as monsters and the creative use of monstrous beings in Jewish culture. Jews have occupied a liminal position within European society and culture, being deeply immersed yet outsiders to it. For this reason, they were perceived in terms of otherness and were often represented as monstrous beings. However, at the same time, European Jews invoked, with...

Quantitative 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 clinical trials and epidemiology that are unique to or particularly challenging in HIV/AIDS research; the second section focuses on the analysis of laboratory data used for immune monitoring, biomarker discovery and vaccine development; the final section focuses on statistical issues in the mathematical modeling of HIV/AIDS pathogenesis, treatment and epidemiology.

This book brings...

Offers a unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development, emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples.

Preeminent Experts Update a Well-Respected Book

Taking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology.

New to the Third Edition

• Four new chapters that present a thorough account...