a quality target product profile (QTPP) was defined for Generic Acetriptan Tablets, 20 mg (see Table 4).基于 RLD 的临床和药动学(PK)特征及体外溶出和理化性质，确定了仿制药 20 mg Acetriptan 片的目标药品的质量概况(QTPP)(见表 4)。Table...
Initially, the quality target product profile (QTPP) was defined based on the properties of the drug substance, characterization of the RLD product, and consideration of the RLD label and intended patient population. Identification of critical quality attributes (CQAs) was based on the severity of ...
Note to Reader: The quality target product profile (QTPP) is “a prospective summary of thequality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product.” 1 The QTPP is an essential element o...
Initially, the quality target product profile (QTPP) was defined based on the properties of the drug substance, characterization of the RLD product, and consideration of the RLD label and intended patient population. Identification of critical quality attributes (CQAs) was based on the severity of ...
临床开发计划是一个新药临床开发的整体计划,而全球注册策略则是支持临床开发,并在全球成功获批上市,并达成目标产品概况(TPP,target product profile)的蓝图。 全球注册策略一般按照以终为始的方法,根据产品的最终临床需求(比如产品说明书product label)和监管机构的上市要求来反推需要的临床数据,根据不同地区监管差异和特...
相比FDA，WHO更早地提出了新冠病毒疫苗目标产品的指南，而且细致到了功效标准、接种程序、保护持续时间等多个方面。此前4月9日，WHO发布的新冠病毒疫苗的目标产品简介（target product profile），基于专家在新冠病毒创新论坛的讨论，列出了WHO对新冠病毒疫苗产品的多项指标希望达到、最低限度应该达到的标准。WHO同时在...
4. For 505(b)(1) applications, what is therationale for selecting the proposed dosage form for the drug product? For505(b)(2) and 505(j) applications, what are the characteristics of thelisted/reference listed drug product? What is the quality target productprofile (QTPP) of the finished...
4. For 505(b)(1) applications, what is therationale for selecting the proposed dosage form for the drug product? For505(b)(2) and 505(j) applications, what are the characteristics of thelisted/reference listed drug product? What is...
Labeling Labeling Overview Overview Jeanne M. Delasko, RN, MS Jeanne M. Delasko, RN, MS Label Initiatives Specialist Label Initiatives Specialist Study Endpoints and Label Development Study Endpoints and Label Development Office of New Drugs, CDER, FDA Office of New Drugs, CDER, FDA 1 ...
4. For 505(b)(1) applications, what is therationale for selecting the proposed dosage form for the drug product? For505(b)(2) and 505(j) applications, what are the characteristics of thelisted/reference listed drug product? What is the quality target productprofile (QTPP) of the finished...