The discovery and development process of the Tamiflu
The Discovery and Development Process of the Tamiflu (R)
Every drug has its own life story that covers its entire journey from conception of an agent as a drug to its final use by a patient. This process is governed by extremely rigorous guidelines. Tamiflu or its generic form Oseltamivir is an anti viral drug used for treatment of and prophylaxis against Influenza A and B has had its own share of controversies and triumphs. It was hailed as a solution to the threat of influenza pandemic but its efficacy and safety profile is now being debated raising questions about the process of approval. Intellectual property and patent concerns also have to be addressed.
Keywords: Tamiflu, Oseltamivir, Influenza, Pandemic.
The drugs that are used to treat various ailments are approved after a rigorous evaluation process. The entire process of development of a drug encompasses many stages and it is only a select few that make the cut. This paper will focus on these stages with special emphasis on Tamiflu. The discussion will cover the drug’s structure, mechanism of action, side effects, optimum dosage and the various questions that are being raised about the drug’s efficacy and the results of post marketing surveillance. Patent laws that govern drugs like Tamiflu will also be discussed.
STEPS INVOLVED IN DRUG DEVELOPMENT AND APPROVAL (Spilker, 2000).
Preclinical phase- an agent is identified by scientists as having the potential to act as a drug on basis of i…
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