Q8 (R2) Step 5 Pharmaceutical Development
excipient, and to support the justification of the drug product specification (3.2.P.5.6). Information to support the safety of excipients, when appropriate, should be cross-referenced (3.2.P.4.6). 2.2. Drug product 2.2.1. Formulation development A summary should be provided describing the development of the formulation, including identification
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