Need well-designed protocol with statistically validated sample size: CDSCO panel tells Dr Reddy's Labs on Nerivio
In line with the proposal to conduct a pivotal clinical investigation of the proposed product Nerivio, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the pharmaceutical giant Dr. Reddy's laboratories that the study should be under a scientifically robust, well-designed protocol with a statistically validated sample size.
In regards to the above, the expert panel suggested the firm submit a revised protocol for further review by the committee.
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B.Sc Life Sciences, M.Sc Biotechnology, B.Ed