FDA在2018年2月发布了《Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questi** and Answers》,本应是针对ICH Q11中的疑惑问题做以解答,但可能是由于其他方面的内容实在没有问题可提,使得本次问答变成了起始物料选择原则的专场表演。FDA一如既往的生怕浪费写作才华的晦涩写法,使得理解起来保持持续烧脑感,笔者特意基于原文内容整理了其中的全部16个问答,希望读者能更加顺畅和愉快的理解其中的内容精髓。
[1] GW Pharmaceuticals Announces the Unanimous Positive Result of FDA Advisory Committee Meeting for First Plant-Based Pharmaceutical Cannabidiol Treatmentfor Seizures in Patients with Two Rare, Severe Forms of Epilepsy
[2] gwpharm官网
[3] LGS和Dravet综合征基金会网页
[4] Marijuana-based epilepsy drug could soon get federal approval, a historic first