Incorporate sample size proportionate with each indication: CDSCO Panel Tells Sun Pharma on Ranibizumab study
Sun Pharma
New Delhi: Reviewing the proposal for conducting the Phase IV study of Ranibizumab Solution for Injection 10 mg/mL, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Sun Pharma to incorporate the sample size proportionate with each indication in the study.
This came after the drug major Sun Pharma presented the proposal for permission to conduct a Phase IV study titled “A prospective, multicenter, single-arm, Phase IV study to assess the safety, efficacy, and immunogenicity of Ranibizumab solution for injection 10 mg/mL (rDNA Origin) vide protocol No. ICR/23/004, version No. 2.0 dated 05.04.2024.
Ranibizumab is a recombinant humanized monoclonal antibody and VEGF-A antagonist used for the management of macular edema after retinal vein occlusion, age-related macular degeneration (wet), and diabetic macular edema.
Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment directed against human vascular endothelial growth factor A (VEGF-A), which is a glycoprotein implicated in the pathophysiology of age-related macular degeneration.
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