注射剂协会(PDA)正在修订无菌药品的技术报告?PDA Revises Technical Report on Sterilized Products May 22, 2012 By: Susan Haigney The Parenteral Drug Association has released a revision of Technical Report 30 (TR 30), Parametric Release of Pharmaceuticals and Medical Device Products TerminallySterilized by Moist Heat. The revised report, originally published in 1999, provides current best practices of the sterile product release method and emphasizes the use of science-based approaches when developing a parametric release program for “pharmaceutical and medical device products terminally sterilized by moist heat.” The original TR 30 outlined a sterility assurance release program that utilized effective control, monitoring, and documentation of a validated sterile product manufacturing process dependent on achievement of critical operational parameters instead of end product sterility testing. A group of international industry scientists, microbiologists, and engineers participated in the revision of TR 30. PDA members can access TR 30 for free until June 15, 2012.查看更多1个回答 . 7人已关注
关于olaparib在中国的状态?各位朋友,我在thomas上查到olaparib在中国的状态如下: CHINA OVARIAN CANCER In January 2011, AstraZeneca planned a regulatory filing in an undisclosed emerging market in 2016 [1164174]. In February 2014, a filing in China for BRCAm PSR ovarian cancer was expected in 2016 [1522992]. In December 2013, a Chinese filing for 1st-line BRCAm ovarian cancer was expected in 2017 [1515365]. In June 2014, filing for 1st-line BRCAm ovarian cancer was expected in 2018 [1581975]. 这是指在2013年已经提交申请了,还是准备在2017年提交申请,另外怎么在CDE网站上查询此类信息,我是登录CDE网站后进入已有批准文号和在审信息查询一栏输入化合物名称:olaparib或者 中文名称 奥拉帕尼 ,搜索结果显示为0,是我没找对方法,还是其他原因,菜鸟一个,请教各位啦。查看更多7个回答 . 15人已关注