Lab to Market

In: Science

Submitted By mommacharly
Words 686
Pages 3
Lab to Market
Charly Batson
March 28, 2014

These days thousands and thousands of dollars are being poured into the development of new drugs and new research to use these drugs effectively. Drug companies run a substantial amount of tests before finding one that works effectively through all the different phases of testing. The process of drug approval is controlled in most countries by a governmental regulatory agency. In the U.S., the Food and Drug Administration (FDA) governs this process. The FDA requires the following phases to be achieved successfully before a drug can be sent to market, preclinical testing, investigational new drug application, phases I clinical trials, phase II clinical trials, phases III clinical trials, new drug application, and post marketing studies.
A preclinical trial is the testing that begins before human testing can be conducted and which important feasibility, iterative testing and drug safety data is collected. This type of data research allows scientists to come up with a safe dosage for humans; typically this is done with animal testing. These tests can usually take around 3 to 4 years, before moving on to the next step. If there are no adverse effects then the drug moves on to the next step, which is investigational new drug application (IND). The pharmaceutical company files an IND with the FDA to begin testing the drug in people. The IND becomes effective if the FDA does not disapprove it within 30 days (medicine.net, 1999). The IND must include the following information: the results of previous experiments; how, where and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in the animal studies; and how the compound is manufactured. The IND must also be reviewed and approved by the Institutional Review Board where the…...

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