QbD里的目标产品质量概况和关键质量属性区别和联系？TPQP is a quantitative surrogate for aspects of clinical safety and efficacy that can be used to design and optimize formulation and manufacturing process. It should include quantitative targets for impurities and stability, release profiles (dissolution) and other product specific performance requirements。 CQAs are physical, chemical, biological or microbiological properties or characteristics that need to be controlled (directly or indirectly) or within an appropriate limit, range, or distribution to ensure the desired product quality。 CMA are physical, chemical, biological or microbiological properties or characteristics of materials including drug substance, excipients, in-process materials and drug product, that need to be controlled to ensure the desired product quality。查看更多
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