There is no content to summarize as the text only mentions the main topic to be summarized:
“Torrent Pharmaceutical gets CDSCO Panel nod to conduct bioequivalence study of Prucalopride oral solution.
However, I can try to provide more context and information on the topic.
CDSCO (Central Drugs Standard Control Organisation) is a part of the Ministry of Health and Family Welfare, Government of India. It is the national regulatory authority for the approval and monitoring of pharmaceutical products in India.
Torrent Pharmaceutical is an Indian pharmaceutical company that develops and manufactures various pharmaceutical products.
The notification states that Torrent Pharmaceutical has received the nod from the CDSCO panel to conduct a bioequivalence study of Prucalopride oral solution. Bioequivalence study is a clinical trial designed to determine whether a generic or biosimilar product is sufficiently similar to the original product in terms of its bioavailability and pharmacokinetic profile.
Prucalopride is a medication used to treat irritable bowel syndrome (IBS) with constipation. It is a serotonin receptor agonist that helps to regulate bowel movements and improve stool frequency and consistency.
The approval from the CDSCO panel is a significant step for Torrent Pharmaceutical, as it enables them to proceed with the bioequivalence study. This study will aim to establish the bioequivalence of their Prucalopride oral solution with the original product. If the study is successful, Torrent Pharmaceutical can apply for regulatory approval to market their version of Prucalopride oral solution in India.
The bioequivalence study will likely involve comparing the pharmacokinetic profiles of the Torrent Pharmaceutical’s Prucalopride oral solution with the reference product. This will typically involve multiple dose administration studies in healthy volunteers, as well as studies in patients.
The approval from the CDSCO panel is a positive development for Torrent Pharmaceutical, as it brings them one step closer to the approval and launch of their Prucalopride oral solution in India.