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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 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.
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.