Revise Phase III CT protocol: CDSCO Panel Tells Dr Reddy's over Tegoprazan
New Delhi: In response to the proposal to conduct a Phase III clinical trial presented by the drug major Reddy's Laboratories, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the firm to revise the protocol of Phase III clinical trial of the drug Tegoprazan with respect to the exclusion criteria number 15 &18 to specify...
New Delhi: In response to the proposal to conduct a Phase III clinical trial presented by the drug major Reddy's Laboratories, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the firm to revise the protocol of Phase III clinical trial of the drug Tegoprazan with respect to the exclusion criteria number 15 &18 to specify that subject’s history of malignancy should be excluded in the study and exclusion of the subject from the study should be based on their previous medication half-lives or as per discretion of investigator.
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