Customer Review: I found the errors in the book absolutely infuriating! Many typos in the text from the first edition are maintained in the second edition. The typos in both text and formulas in the expanded information in the second edition together with gaps in the development of the information made it necessary... more info
Customer Review: This book's best features are its bibliography (about 240 entries) and its broad survey and taxonomy of adaptive methods. Its publication represents an important step in popularizing adaptive trials and, thus, streamlining drug/device/biologic development pipelines. The book is, however, filled... more info
Customer Review: I selected this text for a new doctoral level course on clinical trials based mostly on the topics covered. When we started using it, I found many errors in logical thinking. So far, one of the worst is a view that randomization satisfies some statistical assumption. It does not. Its function is to... more info
Customer Review: When the expiration date on a drug passes, the pharmacist must destroy the items that exceed their shelf life. In a clinical trial, drugs stored for use in the trial can exceed their self life and then must be destroyed. Since the late 1980s the FDA requires that stability testing be conducted to... more info
Customer Review: Chow has done an excellent job of collecting articles from the leading researchers in the pharmaceutical and biologics industry including FDA employees. The terms are specialized but important to those industries. The articles are scholarly and informative. The quality is similar to those in the... more info
Customer Review: This is a very new and unique book that covers the gamut of statistical issues through all phases of drug development. Shao is a distinguished professor from Wisconsin and Chow teaches at Duke University and formerly at Temple but is known for his long career in the pharmaceutical industry.
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Customer Review: This is a great book and an excellent presentation of Stability Theory for those working in the pharmaceutical industry. It is a great reference book on applied statistical methods that all professionals working in this field should have on hand. It is by far the best book on stability theory,... more info
Customer Review: The authors have experience conducting clinical trials in the pharmaceutical industry and this shows in their approach. All the issues that arise in an NDA submission to the FDA are covered. In the introduction the authors describe the regulatory process and the role of the FDA. They even provide... more info
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