Pharmaceutical Product Licensing —— Requirements for Europe

----- 药品许可：欧洲要求

ISBN: 9780136628835 出版年：1991 页码：329 CRC Press

Introduction and history of licensing requirements new active substance products - quality requirements new active substance products - pre- clinical requirements new active substance products - clinical requirements abridged applications drug master files biological products radiopharmaceutical products medicated devices contact lens products experts and expert reports defects in applications - analysis CPMP and its activities CPMP multi-state procedure high EFTA EEC