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 studies will be conducted (Turley, 2009).
When the application is approved that is when the clinical trials in humans may begin. There are three different phases of clinical trials, beginning with small groups and the numbers getting larger as the trials proceed. The first phase will generally involve less than 100 healthy individual volunteers in order to find a safe healthy dose, and evaluate the side effects. Phase I lasts on average of one year. Phase II will involve a larger group of around 300 to 500 hundred volunteers who actually have the disease for which the drug is intended. This phase is done to determine the effectiveness of its therapeutic use and to see what the minimum and maximum dosage is. Phase II typically lasts two years. The last phase, phases III, the drug is administered to several thousand ill patients in exactly the same way that is will be used on the market. Furthermore, there are double-blind studies held with the drug and a placebo, in which, neither the physician nor the patient are aware if they are receiving the drug or the placebo. Phase III is more extensive and will usually last as long as three years (Turley, 2009).
Following the end of phase III clinical trials, the drug company must then submit all of its documentation on the drug to the FDA in a new drug application (NDA). An NDA will usually consist of close to 100,000 pages, and must contain all of the information that was gathered during the clinical trials. The application process can take years to be approved.
In the United States, it takes an average of 12 years for an experimental drug to travel from the laboratory to your medicine cabinet (medicine.net, 1999). There are hundreds of thousands of dollars being poured into medical research, with only about 20 percent of these drugs going to market.
References
"Drug Approvals - From Invention to Market - Medications: Prescription Drugs and Over the Counter Drugs on MedicineNet.com." MedicineNet. N.p., 14 July 1999. Web. 30 Mar. 2014.

Turley, Susan M. "Chapter 2 Drug Design, Testing, Manufacturing, and Marketing."
Understanding Pharmacology for Health Professions. 4th ed. Upper Saddle River, NJ: Prentice Hall, 2009. 27-33. Print.