Drugs in Development: Key Things To Know About The Pharmaceutical Process

Medicine  

Drug discovery and development is a long and complicated process, with costly approvals requiring many steps before introduction to the marketplace. These barriers may fall away as technology progresses, but for now here is how new medicines come to market.

Drugs come onto the market on a continuing basis, providing new options that make treatment easier and more effective for many patients. But the process of producing these drugs is long and arduous, and approval requires many steps before introduction to the marketplace. Here’s a look at how new medications come into regular medical use, from concept to physician prescription:

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Filling A Need

Pharmaceutical researchers must first decide on the kind of medication they wish to develop. This decision may include medical conditions for which no current treatment is available, or for conditions in which current drugs do not produce the required outcome. Researchers must have a significant amount of understanding about the process and mechanisms of diseases in order to find the “target” cells that must be affected to create a favorable result. Then, they experiment on a variety of compounds that cause alterations in these target cells, whether on a cellular or genetic level.

The Role of Serendipity in Drug Development

In some cases, pharmaceutical researchers set out to find a drug to treat a medical problem and find the compound can be used for a completely different condition. Such was the case with Viagra, which was first developed as a treatment for high blood pressure, and Meprobamate, which was developed as a preservative for penicillin, and lithium, which was first used to treat gout and bladder stones. The history of drug development is full of stories of happy accidents that produced treatments for many common medical problems.

Testing and Clinical Trials

Testing and clinical trials on a new drug can go on for ten to fifteen years before sufficient evidence of its effectiveness is available. These tests may be done on cells in the laboratory, and then, it is expanded to living organisms. Many years may pass before testing on humans is begun. Drugs will go through several phases of human trials before sufficient evidence to apply to the FDA for approval. Even after the drug has been approved for patients, additional testing may go on for years.

Federal Drug Administration Approval

Once an application is submitted to the FDA, clinical trials can begin on humans. The patent on the drug is generally in effect at this time and protects the company’s investment in developing the compound. A specialist with a master's in healthcare says this patent will remain in effect for a number of years after the drug is approved. If the clinical trials continue to produce safe and effective results, the FDA then approves the drug for distribution to the public. Each new drug brought to market has undergone thorough investigation and testing. These measures ensure that physicians can rely on medications to provide appropriate treatment for patients under their care.

By Emma Sturgis

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