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
Second development phase: pre-formulation study
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