Developing new drugs is a costly prospect. A pharmaceutical may spend upwards of $400 million dollars just to get one new drug out on the market. And this is for the drugs that actually make it this far, not the ones that are discarded earlier in the development process.

Preclinical Testing

This is the first testing phase for developing new drugs. This stage involves lab work to test how well a drug works against a given illness. These studies are conducted on animals to evaluate the ability of the drug to work in a living being. At the same time, this drug must be checked to see if it will be safe for anyone to potentially use. This stage can take 3 or 4 years to finish.

Investigational New Drug Application

The next step is for the pharmaceutical company to file one of these applications to get clearance to begin testing this new drug on human test subjects. The FDA has 30 days to contest the application before it becomes effective. The Investigational New Drug Application contains information on the experiments that have been carried out thus far and on the proposed future experiments for human testing.

It also contains information on the actual chemical makeup of the new drug, how it functions within the body, any adverse effects that were discovered in the course of the animal testing, and how the drug is made. This application must be accepted by the Institutional Review Board and those conducting the study must send progress reports to the FDA at least once a year.

Clinical Trials

Once all of the above steps have taken place and the application has been approved, then the clinical trials can begin. The clinical trials usually happen in three separate phases. The first phase takes up to a year.

This first phase can include anywhere from about 20 to 80 test subjects and is really the preliminary step in finding out how a drug works in human subjects. This first phase of trials is meant to determine the safe dosage range for human subjects as well as the overall safety of the drug for humans. It also evaluates drug absorption, distribution, and how long well it performs its task.

The second phase involves a greater amount of test subjects, perhaps 100 to 300. This group of individuals all have the condition that the drug was designed to treat. This stage of testing keeps a close eye on how well the drug performs in a person with the condition and lasts around 2 years.

The third phase takes about 1,000 to 3,000 subjects in hospital setting and has doctors keep track of any and all drug effects. This phase typically takes about 3 years. After this, the drug is proposed to the FDA. Whether it is approved is up to the FDA.

This is a basic outline of how pharmaceutical companies develop new drugs. It is a long and costly process and explains high drug prices. Each new medication has a lot of time and money behind it.

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