Risks and Benefit Analysis of Medications

Kumar Anoop

Department of Pharmacology and Clinical Research, Delhi Pharmaceutical Sciences and Research University Pushp Vihar, Sec-III, MB Road, New Delhi, INDIA


Risk and benefit ratio of drugs from clinical trials determines whether a candidate drug is suitable for marketing. The regulatory authority authorized the product if the benefits outweigh the risks. This balance might be change later once drug reach into the market as a result of exposure in a large number of patients, concomitant medications and diseases, long-term exposure, confounding factors, and so on. For example, benefit might be 90% and risk 10% when the first periodic safety update report (PSUR) is submitted. These percentages might have changed when the fifth PSUR is submitted (benefit 60% and risk 40%). Therefore, periodic re-examination of the risk and benefit profile of medications is required to ensure that the balance remains favourable. The talk is started with basics of risks and benefit profile of medications. Further, key findings of completed work at DPSRU i.e., “identification of novel signal of clindamycin associated acute renal failure and identification of novel signals of proton pump inhibitors (PPIs) on renal system” are also presented. The ongoing work i.e., identification of novel signal and prediction of mechanism of ADRs using Network Pharmacological approaches in Department of Clinical Research at DPSRU is also highlighted.  

Article ID: O0401019 (Suppl 1)   RA  Preprint
Received: 08/06/2022 
Accepted: 08/07/2022
Published: 08/08/2022

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