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What is Drug Development?
Mary McMahon
Mary McMahon
Drug development is a process which takes a drug from initial discovery to the pharmacy shelves. Very few pharmaceutical products actually make it all the way through drug development, and sometimes the process can be an extremely costly and frustrating failure. Drug companies and scientific researchers persist with drug development and research because they are interested in finding new and potentially useful drugs, and because the steady release of new drugs is usually the cornerstone of profits.
The stages of drug development begin with the identification of a compound which may have a therapeutic use. This compound could come from a natural source, a random discovery in a lab, or a targeted effort to develop a compound which addresses a particular issue. Once this compound has been identified, tests can be used to determine its precise chemical makeup, and to learn how effective it is, and what it could be used for.
If the pharmaceutical company believes at this stage of the drug development process that it may have a useful compound, it can start to file paperwork with regulatory agencies, identifying and naming the compound so that the agencies can start reviewing it. At the same time, a lengthy series of tests and trials begins, typically starting in the lab, moving to animals, and eventually being expanded to humans in carefully monitored clinical trials. The results of these tests must all be supplied to the regulatory agency as part of the drug's application for approval.
At every 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 severe side effects which can be detrimental to human health. Efficacy is also important, as drug companies want to make drugs which will actually work, ideally in new and innovative ways. The conditions which the drug can be used to treat may also be a cause of concern, as some avenues of exploration are more likely to generate profitable returns than others. Allergy medications, for example, generate more of a return on investment than drugs which treat tuberculosis.
If the drug makes it through early design and testing and it is approved by a regulatory agency, the company can present it for sale. Packaging for sale usually includes the determination of correct dosages, and the formulation of a drug in a form which will be easy to administer accurately. The pharmaceutical company must also develop packaging which discloses known side effects, risks, and adverse drug interactions.
Mary McMahon
Ever since she began contributing to the site several years ago, Mary has embraced the exciting challenge of being a WiseGEEK researcher and writer. Mary has a liberal arts degree from Goddard College and spends her free time reading, cooking, and exploring the great outdoors.
Learn more...
Mary McMahon
Ever since she began contributing to the site several years ago, Mary has embraced the exciting challenge of being a WiseGEEK researcher and writer. Mary has a liberal arts degree from Goddard College and spends her free time reading, cooking, and exploring the great outdoors.
Learn more...AS FEATURED ON:
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![Negative drug interactions must be determined and disclosed during drug development.]()
By: JJAVANegative drug interactions must be determined and disclosed during drug development. -
![The development of a new drug is a long and uncertain process.]()
By: Gennadiy PoznyakovThe development of a new drug is a long and uncertain process.
Discussion Comments
Drug development sounds like an extremely tedious, long process. I would not want to be the person in charge of overseeing an operation like this!
Also, drug companies are always getting sued years after people have been using their drugs. I hear about a new class action lawsuit nearly every day on television or in the newspaper.
I think that if you are willing to risk side effects in order to get relief out of a drug, then you should take responsibility for that risk. Don’t go accusing the company that made the drug of making you sicker, because they probably had no idea that it would cause something bad to happen!
@OeKc05 - I can’t speak for all pharmaceutical research centers, but I can tell you that the clinical trial that I am involved in was looking for people with polycystic kidney disease. In addition to that, the test subjects had to be in a certain stage of the disease and have no other health problems.
The research leader told me that I would experience extreme thirst and frequent urination while on the drug, but this was how it worked. The drug was trying to dehydrate the cysts in my kidneys, and to do so, it had to dehydrate all of me.
Some people were able to endure the effects, but I couldn’t handle it. I was having to urinate a ton every thirty minutes, and no amount of water could satiate my thirst. I drank over 2 gallons of water in one day while on the drug!
Also, it made my blood pressure shoot up sky high. I got episodes of shaky hands, and I had to stop taking the drug. I was afraid it might be doing more harm than good.
I’ve often wondered what it’s like to be involved in the clinical trial phase of drug development. I know that drug companies will pay people to serve as guinea pigs, and I have even considered offering up my body as a test tube!
Do drug companies just accept anyone who is in good health, or do you have to have a certain condition? Are they looking to see what sort of side effects occur in healthy people, or does a person need to have a disease in order to participate? It seems like an easy way to make money, provided that the side effects aren’t too awful, and since the drug would have already been tested on animals, it would probably be safe.
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