Homework [Study Per­for­mance]

posted by Ohlbe – France, 2018-02-22 10:19  – Posting: # 18446
Views: 2,427

Dear Lakshmipathy,

» For test they are using old IPs and reference they are getting new IPs of same batch for the conduct of study. Our doubt is whether we have to have retention quantity for both old study and new study.

Then I will ask the same question again: what exactly do you not understand in section IV of the FDA guidance ? Did you read it carefully ? What is your opinion ?

Regards
Ohlbe

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