Single dose PK study on Patients [Design Issues]

posted by Ohlbe – France, 2024-05-15 11:39 (5 d 17:19 ago) – Posting: # 23997
Views: 349

Dear Pharma_88,

You are referring to a general FDA guidance, which gives general recommendations. Did they publish a product-specific guidance for your product ? It would overrule the general guidance.

The type of study to be performed depends on how the drug is normally used according to its labelling. For instance:

Regards
Ohlbe

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