Advances in Pharmacoepidemiology and Drug Safety

Division of Pharmaceutical Evaluation and Registration (P.E&R), Drug Regulatory Authority of Pakistan (DRAP), Islamabad, Pakistan

Publications

• Review Article   
  Safety Review of Quinolone and Fluoroquinolone Containing Medicinal Products: Global Regulatory Scenario and Way Forward
  Author(s): Muhammad Junaid Farrukh, Syed Azhar, Syed Sulaiman and 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 Drugs are withdrawn from the market if serious adverse events appeared even after approvals like withdrawal of rofecoxib [1]. .. View more»
  

  Abstract PDF