Drug products for clinical trials: an international guide to formulation, production, quality controlКНИГИ » ЗДОРОВЬЕ И МЕДИЦИНА
Автор: C.T. Rhodes, Donald C. Monkhouse Название: Drug products for clinical trials: an international guide to formulation, production, quality control Издательство: CRC Press Год: 1997 ISBN: 978-0824798529 Серия: Drugs and the Pharmaceutical Sciences (Book 87) Язык: English Формат: pdf Размер: 20,7 mb Страниц: 406
The only wide-ranging, up-to-date book of its kind available on the subject! Describing both the science and management of product development, Drug Products for Clinical Trials furnishes effective approaches for preclinical drug discovery addresses the function of the clinical trials materials manager covers the design of clinical protocols in developing a new chemical entity (NCE) explains the importance of bioequivalence between clinical trials materials and final products demonstrates rapid, reliable processes for clinical evaluation discusses the interaction between clinical research, manufacturing, and packaging reviews quality control strategies used in the manufacture of drug substances for clinical studies conducted throughout the world and much more!