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Drug development is a costly and often frustrating process that involves identifying a potentially useful compound, testing it for safety and efficacy, and submitting it for regulatory approval. Success depends on addressing concerns such as safety, efficacy, and potential profitability. If approved, the drug can be packaged and sold with information about its risks and side effects.
Drug development is a process that takes a drug from initial discovery to pharmacy shelves. Very few pharmaceuticals actually make it past drug development, and sometimes the process can be an extremely costly and frustrating failure. Drug companies and scientific researchers persist in drug development and research because they are interested in finding new and potentially useful drugs and because the constant release of new drugs is usually the cornerstone of profits.
The stages of drug development begin with the identification of a compound that may have a therapeutic use. This compound could come from a natural source, a chance discovery in a lab, or a focused effort to develop a compound that addresses a particular problem. Once this compound is identified, tests can be used to determine its precise chemical composition and to learn how effective it is and what it could be used for.
If the drug company believes at this stage in the drug development process that it might have a useful compound, it can begin submitting paperwork to regulatory agencies, identifying and naming the compound so the agencies can begin reviewing it. At the same time, a long series of tests and trials begins, typically starting in the laboratory, moving to animals, and eventually extending to humans in carefully monitored clinical trials. The results of these tests must all be provided to the regulatory agency as part of the drug’s approval application.
At each stage of the drug development process, several concerns must be addressed. The first is safety: a compound is useless if it is extremely toxic, for example, or if it has serious side effects that can be harmful to human health. Efficacy is also important, as pharmaceutical companies want to make medicines that actually work, ideally in new and innovative ways. The conditions that the drug may be used to treat may also be a cause for concern, as some avenues of exploration are more likely to generate lucrative returns than others. Allergy drugs, for example, generate a higher return on investment than drugs that treat tuberculosis.
If the drug passes initial design and testing and is approved by a regulatory agency, the company can submit it for sale. Packaging for sale usually includes determining the correct dosages and formulating a drug in a form that will be easy to administer accurately. The pharmaceutical company must also develop packaging that reveals the side effects, risks and adverse interactions of known drugs.
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