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IND-Enabling DMPK Study Package

The term IND (investigational new drug) refers to a new drug to be evaluated in clinical trials. An IND application is a request for authorization by the FDA/CFDA to administer an investigational drug to humans. Such an application is composed of sets of IND-enabling studies, among which DMPK studies represent an essential part. The DMPK study contents required by the FDA/CFDA in their IND approval processes are quite similar though there are minor differences. Over the past six years, 3D BioOptima has completed over 100 IND-enabling DMPK package studies for our clients (6 for BeiGene alone), with all our work passed regulatory inspections. Over 60 of them have been approved to enter into clinical trials by CFDA and over 30 of them by US FDA and Australian TGA.

Typical IND-enabling DMPK Study Package

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