Bioequivalence and Bioavailability Forum

soma pillai ☆ 2009-08-10 11:43 (5753 d 21:40 ago) Posting: # 4025 Views: 4,647	Failure in preparation of IPs [GxP / QC / QA] Post reply
	Dear all, How one can know whether any BA/BE study fails due to error in formulation preparation ? Regards, Soma Pillai Edit: Category and subject line changed. Please try to be more specific in the future! [Helmut]

Helmut
★★★

Vienna, Austria,
2009-08-10 19:36
(5753 d 13:47 ago)

@ soma pillai
Posting: # 4033
Views: 3,564

cGMP prerequisite of BE!

Post reply

Dear Soma!

❝ How one can know whether any BA/BE study fails due to error in formulation

❝ preparation ?

Oops! I hope you are talking about a (few) suspected case(s) in a study.
Conformity with cGMP is a prerequisite of BE! You may suspect anything, but:

If you are able to track down an error in the preparation of IPs, fine, but I would expect your chances to remove these suspects after the study was unblinded and evaluated to be very low.
If you don't find the error (=documented: no oral lore!), your chances are close to nil.

In either case it casts a damning light on the conformity with cGMPs. Even if the study is accepted - which I don't believe - prepare for a thorough cGMP/GCP inspection soon.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Failure in preparation of IPs [GxP / QC / QA]

cGMP prerequisite of BE!