And the FDA… [GxP / QC / QA]

posted by Helmut Homepage – Vienna, Austria, 2024-06-19 13:22 (28 d 13:44 ago) – Posting: # 24031
Views: 1,092

Dear Ohlbe and all,

Notification to Pharmaceutical Companies: Clinical and Bioanalytical Studies Conducted by Synapse Labs Pvt. Ltd. are Un­ac­cept­able (June 18, 2024)

FDA is notifying sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) that clinical and bioanalytical studies conducted by Synapse Labs Pvt. Ltd. (Synapse)—a contract research organization (CRO) based in Pune, India—are not acceptable because of data integrity concerns. Studies conducted by Synapse must be repeated.
(my emphasis)

More details. Overlapping profiles, small differences in individual concentrations, etc. One study was performed in four groups and the FDA assessed a group-by-treatment interaction followed by Bayesian Shrinkage.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
23,107 posts in 4,858 threads, 1,644 registered users;
56 visitors (0 registered, 56 guests [including 9 identified bots]).
Forum time: 03:06 CEST (Europe/Vienna)

All paid jobs absorb and degrade the mind.    Aristotle

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5