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:


Complete thread:

UA Flag
 Admin contact
23,033 posts in 4,835 threads, 1,647 registered users;
32 visitors (0 registered, 32 guests [including 3 identified bots]).
Forum time: 04:58 CEST (Europe/Vienna)

Give me a fruitful error any time, full of seeds, bursting with its own corrections.
You can keep your sterile truth for yourself.    Vilfredo Pareto

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz