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.
Offers a unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development, emphasizing biopharmaceutic...
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...
Preeminent Experts Update a Well-Respected Book
Taking into account the regulatory and scientific developments that have occurred s...
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...
As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to...
