2020年4月14日 · The quality target product profile (QTPP) describes the design criteria for the product, and should therefore form the basis for development of the CQAs, CPPs, and...

Assess drug substance/product, manufacturing (process and facility inspections), biopharmaceutics, and microbiology quality aspects of an ANDA application. Establish QTPP to ensure the desired...

MaPP 5015.10 finalized by US FDA in 2014 clarifies the concept of QbR. There is MicroQbR available which includes questions confirming the sterility of the product.

ICH Q8 defines QTPP as “A prospective summary of the quality 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”.

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

2024年12月13日 · What is QTPP? QTPP is a summary of key attributes a generic product must possess to match the original branded drug (RLD). It focuses on delivering the same therapeutic benefits, considering factors such as the intended use, …

2015年10月1日 · The Quality Target Product Profile (QTPP) provides an understanding of what will ensure the quality, safety, and efficacy of a specific product for the patient

目标产品质量概况 (Quality Target Product Profile ,QTPP)： 指理论上可以达到的、并将药品的安全性和有效性考虑在内的关于药品质量特性的前瞻性概述。 实时放行检验(Real Time Release Testing)：

目标产品特征（Target Product Profile，TPP） 是表明计划研发的试验药最理想特征的文件，是对新产品的预期安全性、有效性/有效性和价值主张的预测，并支持公司在技术设计、战略证据生成和未来营销策略方面的决策。 TPP最初出现于美国企业内部，形式各不相同，用于讨论新药开发的研发计划，后来更常用于促进企业与 FDA （监管机构）之间的讨论。 一项针对FDA提交的申请的文件资料研究发现， 那些使用TPP的产品全部通过了 IND 的申请，并且上市的整体时间比没 …

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be...