First development phase: identification of the product's target quality profile and its critical attributes
Quality risk management applied to pharmaceutical product development
Article REF: PHA3051 V1
First development phase: identification of the product's target quality profile and its critical attributes
Quality risk management applied to pharmaceutical product development

Authors : Jean-Jacques HOURI, Mélisande BERNARD, Hassane SADOU-YAYE, Bernard DO

Publication date: February 10, 2016 | Lire en français

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2. First development phase: identification of the product's target quality profile and its critical attributes

The QTPP can be defined on the basis of clinical data, the pharmacokinetic characteristics of the active substance and the commercial objectives to be achieved. The example of QTPP presented in table 2 can of course be re-evaluated at a later stage, in the light of knowledge acquired during the development process.

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First development phase: identification of the product's target quality profile and its critical attributes

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