Tom Brody: 5 books

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...

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...

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...

Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent...

A balanced, accessible discussion of whether and on what grounds animal research can be ethically justified. An estimated 100 million nonhuman vertebrates worldwide—including primates, dogs, cats, rabbits, hamsters, birds, rats, and mice—are bred, captured, or otherwise acquired every year...