Pilot study data submission as pivotal study [Off Topic]

posted by qualityassurance – 2023-10-02 14:06 (254 d 21:50 ago) – Posting: # 23728
Views: 1,614

Dear forum members,

If pilot study passes the bio-equivalence criteria with 12 evaluable subjects, can it be submitted to the regulatory authority instead of conducting another pivotal study based on ethical reason and to avoid any unnecessary exposure of drug to healthy human subjects?

Interesting to know the opinions.

Thank you.

Complete thread:

UA Flag
 Admin contact
23,056 posts in 4,840 threads, 1,641 registered users;
47 visitors (1 registered, 46 guests [including 6 identified bots]).
Forum time: 11:57 CEST (Europe/Vienna)

Everything is trivial, if you know the answer.    Thomas Jaki

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