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Search results with tag "Considerations for pharmaceutical product lifecycle"

Q12 Step 5 Technical and regulatory considerations for ...

Q12 Step 5 Technical and regulatory considerations for ...

www.ema.europa.eu

considerations for pharmaceutical product lifecycle management - annexes Step 5 . ... Therefore, changes in these process parameters and specification are reported as NM. Enhanced Parameter-Based Approach • API PSD: − EC: The impact of PSD of API on blend homogeneity and dissolution was well understood. DoE studied PSD within 5-200 um.

  Product, Pharmaceutical, Specification, Lifecycle, Considerations, Considerations for pharmaceutical product lifecycle

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