The US Food and Drug Administration (FDA) announced an unspecified number of pharmaceutical companies that data from all studies of bioequival in vitro conducted by NAVI Mumbaj contractual research organization (CRO) RAPTIM Research LTD “must be rejected” for data falsification. The letter states that the FDA identified data counterfeiting for “multiple subjects/samples in multiple studies”.
The FDA looked at the company from 24 April to 28 April 2023 and also analyzed data after the inspection.
The letter also says that because Raptim’s research was “responsible for creating false data about the in vitro study”, there is no reason to believe that any data in vitro, which has created Raptim (research), are reliable. ” Therefore, the FDA “found that all study data from all in vitro studies performed on RAPTIM (research) must be rejected.” The drug regulator told companies that the data generated by RAPTIM research will not be enough to support the bioequival. Companies have been asked to re -end in vitro studies for an alternative study in addition to Raptim’s research.
In E -mail of 27 March 2025, FDA told Rajen Shah, the owner and director of Raptim Research that “significant inappropriate conditions” were observed during the inspection and data analysis. According to E -mail, the FDA sent a general letter (GSL) a general letter (GSL) a general correspondence letter (GSL) and asked the company to provide specific answers to concerns that they had raised on the submitted data submitted. The FDA observed “almost identical profiles of concentrations between different donors in different studies for different sponsors”.
Regarding FDA concerns about data falsification, she said that “in vitro study led to the submission of false FDA information about the measurement of the bioavailability of a medicinal product or a demonstration that the medicinal product is bioequivalent for reference drugs”.
September 4, 2024 and 17 October 2024, the company failed to “reasonably address FDA concerns or significantly explain what caused significant data anomalies” in studies, led to the FDA to send a letter on March 27, 2025. It solves the identified pattern of problems in vitro and in vivo ”.
Published – April 5, 2025 20:34
