And the FDA… [GxP / QC / QA]

posted by Helmut Homepage – Vienna, Austria, 2024-06-19 13:22 (87 d 09:29 ago) – Posting: # 24031
Views: 2,048

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.
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