Drug Safety Process
B.S. Pharmacy, King Saud University, 2007
Table of content
1- Introduction to drug safety
2- The Drug Studies on Safety.
1- Pre-Approval studies
2- Post-Approval studies
3- Post marketing Studies
Pharmaceutical companies today like to produce many new drugs, but there are several potential risks associate with the production of any new medicine. In addition, there is numerous new side effects come from approved drugs. This paper aims to help understand and perform the safety of drug uses. Method
A literature search for articles that discuss Drug safety before, during, and after its approval was performed using PubMed and Food and Drug Administration (FDA) websites. Review articles, between 2000- 2009, related to drug safety and pharmacovigilance (detecting, assessing and preventing drugs side effects) were discussed to investigate the adverse effects of any drug. Results
Introduction to drug safety
After the introduction of Sulfanilamide in 1983, the first sulfa antimicrobial drug, one hundred and five patients died due to its toxicity. Because of this tragedy, the American Congress established the Food, Drug and Cosmetic Act, which asked the pharmaceutical companies to provide sufficient researches about the safety of any new drug before its release. Since that time, the Food and Drug Administration requires proofs of safety and efficacy for the new drugs before approval. These proofs should include sufficient clinical trials on human to validate both efficacy and safety.(Liu, 2007) Pre-Approval studies:
Drug safety is more important than its efficacy, therefore the FDA requires extensive animal studies for any new drug before its approval and before any clinical trials. After the approved effects on animals, human trials start in three stages to insure its safety on human, stage 1 focuses on the...
References: (FDA), F. a. D. A. (2009). Guidance for Industry Postmarketing Studies and Clinical Trials - Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act. from <http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172001.pdf>
Galson, S. (2005). Drug safety/ drug approval process. from <http://www.fda.gov/NewsEvents/Testimony/ucm161673.htm>
Liu, J. (2007). Rethinking statistical approaches to evaluating drug safety Yonsei Med J, 48(6), 895-900.
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