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Dr. Reddy's Laboratories gets CDSCO Panel Nod for BA/BE study of Ketorolac Tromethamine Sustained Release Tablet
![Dr. Reddys Laboratories gets CDSCO Panel Nod for BA/BE study of Ketorolac Tromethamine Sustained Release Tablet Dr. Reddys Laboratories gets CDSCO Panel Nod for BA/BE study of Ketorolac Tromethamine Sustained Release Tablet](https://medicaldialogues.in/h-upload/2024/01/20/750x450_230651-dr-reddys-new-50.webp)
New Delhi: The drug major Dr Reddy's Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Bioavailability/Bioequivalence studies (BA/BE study) of nonsteroidal anti-inflammatory drug Ketorolac Tromethamine Sustained Release Tablet 30 mg for export purpose only.
This came after Dr. Reddy's Laboratories presented the proposal along with a justification of study design about the comparability of the pharmacokinetics of immediate release vs sustained release dosage form with supportive documents before the committee.
Ketorolac is used to relieve moderately severe pain, usually pain that occurs after an operation or other painful procedure. It belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
The primary mechanism of action responsible for ketorolac's anti-inflammatory, antipyretic, and analgesic effects is the inhibition of prostaglandin synthesis by competitive blocking of the enzyme cyclooxygenase (COX). Ketorolac is a non-selective COX inhibitor. It is considered a first-generation nonsteroidal anti-inflammatory drug (NSAID).
At the recent SEC meeting for analgesic and rheumatology held on 2nd May 2024, the expert panel reviewed the proposal along with the justification of the study design with regard to the comparability of the pharmacokinetics of immediate release vs sustained release dosage form with supportive documents before the committee.
After detailed deliberation, the committee recommended the grant of permission to conduct the BA/BE study for export purposes only.
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.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751