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Need well-designed protocol with statistically validated sample size: CDSCO panel tells Dr Reddy's Labs on Nerivio
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Overview
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.
For more details, check out the link given below:
Speakers
Isra Zaman
B.Sc Life Sciences, M.Sc Biotechnology, B.Ed
Isra Zaman is a Life Science graduate from Daulat Ram College, Delhi University, and a postgraduate in Biotechnology from Amity University. She has a flair for writing, and her roles at Medicaldialogues include that of a Sr. content writer and a medical correspondent. Her news pieces cover recent discoveries and updates from the health and medicine sector. She can be reached at editorial@medicaldialogues.in.