Anmerkungen:
Includes bibliographical references and index
Beschreibung:
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