Nutritional Biochemistry takes a scientific approach to nutrition. It covers not just "whats"--nutritional requirements--but why they are required for human health, by describing their function at the cellular and molecular level. Each case study either leads to a subsequent discovery or enables an understanding of the physiological mechanisms of action of various nutrition-related processes. The text is "picture-oriented" and the commentary is directed towards explaining graphs, figures, and tables.
Nutritional Biochemistry includes a discussion of relevant aspects of physiology, food chemistry, toxicology, pediatrics, and public health. Experimental techniques for nutritional science are emphasized, and primary data is included to help give students a feel for the nutrition literature. This "real-world" approach provides students with a realistic view of the basis for much of our understanding of nutritional biochemistry.
* Integrates biochemistry and nutrition in a case-oriented method
* Emphasizes a hands-on approach to learning - case histories and clinical and research data illustrate all major points
* Places emphasis on metabolism - metabolic pathways, enzymology, nutrient requirements (including RDA values)
* Reveals the benefits of the Mediterranean diet, the biochemistry of exercise, the cell signaling pathways, how nutrition can influence the development of cancer, and the anthropometry and genetics of obesity.

FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label.

Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials.