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2011年全球新药研发再掀高潮,美国FDA批准上市的新药数目创近5年新高,《2007-2011年美国FDA批准新药概况》一文就2007-2011年美国FDA批准的在几大重点治疗领域--心血管疾病、肿瘤、感染性疾病、代谢疾病、风湿疾病等的治疗性新药进行了简单介绍,对新药研发人员具有参考意义。由于创新性药物的药学研究具有渐进性和不确定性,决定了其研究进程中必然存在各种变更。《创新性药物研发过程中药学变史的相关考虑》总结了创新性药物研发过程中药学变更的常见原因、评价核心、主要变更类型、各类变更的技术考虑要点,并以实例对研究思路做了进一步阐述。药用辅料是影响药品安全的重要成分之一。
2011 global new drug research and development culminating again, the US FDA approved the listing of new drugs hit a record high of nearly 5 years, “2007-2011 US FDA approval of new drugs profile” on the 2007-2011 US FDA approved in several key areas of treatment - - Cardiovascular disease, cancer, infectious diseases, metabolic diseases, rheumatic diseases and other therapeutic new drugs were briefly introduced for new drug researchers have reference value. Due to the gradual and uncertain pharmaceutical research on innovative drugs, it is inevitable that various changes must be made in the research process. “Relevant Considerations on Pharmacological History of Innovative Drug Development” Summarizes the common causes of pharmacovigilance, the core of evaluation, the main types of changes, and the technical considerations for various changes in the development of innovative drugs. The examples are given to the research ideas Further elaboration. Pharmaceutical excipients are one of the important ingredients that affect the safety of medicines.