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Justify rationality for FDC Sitagliptin, Lobeglitazon: CDSCO Panel Tells Synokem Pharma
New Delhi: In line with the drug major Synokem pharmaceutical's proposal for deliberation of bioequivalence (BE) and phase III clinical trial protocol of the fixed-dose combination (FDC) Sitagliptin Phosphate monohydrate IP 100mg plus Lobeglitazone sulfate 0.5mg Film-Coated tablets, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO)...
New Delhi: In line with the drug major Synokem pharmaceutical's proposal for deliberation of bioequivalence (BE) and phase III clinical trial protocol of the fixed-dose combination (FDC) Sitagliptin Phosphate monohydrate IP 100mg plus Lobeglitazone sulfate 0.5mg Film-Coated tablets, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined that the firm should justify rationality for combining this FDC and its significant benefit.
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.