Bøker av Shayne C. Gad

This fourth edition provides tools for the rigorous and critical analysis of experimental data. Assuming only basic mathematical skills, the book provides a complete and exhaustive introduction to the statistical methods available and updates all material to cover current practices. The author also provides three entirely new and up-to-the-minute chapters: one provides the first practical guide to performing meta analysis that allows for the power inherent in multiple similar studies; two others cover Bayesian analysis and data analysis in pharmacology, discussing analysis of receptor binding assays, safety pharmacology assays, and other standard study types conducted in pharmacology.

Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazardΓÇöparticularly in individuals with compromised or limited organ system functions.Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the authorΓÇÖs more than 30 years of direct experience, the book incorporates tricks and practical insights for making studies work and understanding why they fail. The second edition includes current regulations, including USFDA and those from Europe and Japan. Presenting a clear description of what is needed and why for supporting drug development, the book focuses on updated test methods, interpretation, and science. It covers the core and supplemental batteries of test procedures and how to do them and provides an overview of available facilities and contract organizations for performing studies.

Contract Research and Development Organizations provides a how-to guide for all aspects of working with CROs. The text focuses on in selection and workflow aspects to ensure the best possible outcome of outsourcing the R&D function.

This book is a guide for personnel in the pharmaceutical and medical device industries. It will give you the peace of mind that you've thought through all the angles and made well-informed decisions.