Intas Pharmaceuticals Gets CDSCO Panel Nod to Study Recombinant Human Follicle Stimulating Hormone
New Delhi: Intas Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I clinical trial of the Recombinant Human Follicle Stimulating Hormone 300 IU Solution for Injection.
However, this approval is subject to the condition that the firm should have tied up with an IVF center in case of an emergency.
This came after the firm presented the protocol to conduct a Phase I clinical study of Recombinant Human Follicle Stimulating Hormone 300 IU Solution for Injection titled " An open label, Phase-I, balanced, randomized, two-treatment, two-period, two-sequence, single subcutaneous dose administration, crossover, bioequivalence study of r-h-FSH (recombinant human follicle stimulating hormone injection), solution for injection of Intas Pharmaceuticals Limited, India with Gonal-f, recombinant human follicle stimulating hormone (r-hFSH) follitropin alfa, solution for injection of Merck serono Ltd. in pituitary down-regulated normal, healthy, adult, human female subjects under fasting conditions." vide Protocol no. 0501-23, Version: 2.0 dated 27-May-2024.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.