Pharmaceutical analysis for small molecules / edited by Behnam Davani, Principal Scientific Liaison, General Chapters, Science Division, U.S. Pharmacopeia
Drug approval process and regulatory requirements / Roger Dabbah -- Pharmacopeias and compendial approval process / Roger Dabbah -- Common methods in pharmaceutical analysis / Behnam Davani -- Common calculations / Behnam Davani -- Analytical method validation, verification, transfer / Behnam Davani -- Specifications / Ernest Parente -- Impurities / Behnam Davani -- Good documentation practices / Afsaneh Motamed Khorasani -- Management of analytical laboratories / Roger Dabbah -- Analytical instrument qualifications / Shaligram Rane and Rustom Mody
Summary
Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs
Bibliography
Includes bibliographical references and index
Notes
Print version record and CIP data provided by publisher
