质量目标产品概况(Quality Target Product Profile ,QTPP)是对药品质量特性的前瞻性总结,在考虑药品的安全性和有效性后,理想情况下应达到这些质量特性,以确保达到预期的质量。QTPP构成了产品设计和开发的基础。QTPP推动了产品质量特性的定义。分析目标概况(...
质量源于设计 (Quality by Design, QbD)的开发方法首先要根据患者在用药剂量、便利性和依从性方面的需求,以及预期治疗适应症的市场要求,明确定义目标产品特征 (Target Product Profile, TPP)。 产品要求可分为以下三个方面 (Figure 13-1): 1. 产品稳定性,在患者使用前保持一致的产品质量; 2. 可制造性,即生...
This is because lower drug exposure can result in a partial or complete loss of the desired therapeutic effect, which is why the therapeutic range is often a critical part of a drug’s target quality product profile as outlined in the...
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 ...
Target Product Profile: A Renaissance for its Definition and Use The Target Product Profi le (TPP) is supposed to be the cornerstone of pharmaceutical product development. But how often is it utilized or updated, and how closely does it resemble the product that originally was envisaged? At a...
质量目标产品概况 (Quality Target Product Profile ,QTPP)是对药品质量特性的前瞻性总结,在考虑药品的安全性和有效性后,理想情况下应达到这些质量特性,以确保达到预期的质量。QTPP构成了产品设计和开发的基础。QTPP推动了产品质量特性的定义。分析目标概况 (Analytical Target Profile ,ATP)是分析方法的同义词。 在确...
aThe target product profile reflects characteristics needed to differentiate a product in the marketplace. The ideal product profile is one that would make the drug the new gold standard-recognized best therapy-for the disease or symptoms it is meant to treat. The profile required for a successful...
Drug sponsors and intellectual property (IP) owners under_x0002_stand how critically important it is to establish the target productprofile (TPP) of the proposed drug product as early as possible.The TPP provides regulators with a summary of the prospectivedrug development program and its drug ...
Quality Target Product Profile 目标产品质量概况 CQA Critical Quality Attributes 关键质量属性 CPP Critical Process Parameters 关键工艺参数 QCPP Quality Critical Process Parameter 质量关键工艺参数 RA Risk Assessment 风险评估 DS Design Space 设计空间
product formulation and process are expected to be robust in meeting the characteristics defined in the regulatory quality target product profile (QTPP). In this phase, the drug product development experts should work collaboratively with the process validation team to establish the produc...