薬物疫学と医薬品の安全性の進歩

概要

Safety Review of Quinolone and Fluoroquinolone Containing Medicinal Products: Global Regulatory Scenario and Way Forward

Muhammad Haseeb Tariq, Muhammad Junaid Farrukh, Syed Azhar, Syed Sulaiman, Obaidullah

Drugs are introduced into the market for use by the patients after year’s long drug development processes including extensive clinical trials and stringent approval pathway by drug regulatory authority keeping in view safety, efficacy and quality parameters. Drugs are usually approved after successful completion of phase III clinical trial. Post marketing surveillance or phase-IV clinical trials are focused on long term safety studies and may continue for years. Drugs are withdrawn from the market if serious adverse events appeared even after approvals like withdrawal of rofecoxib [1].