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Chemical and Process Engineering Resources

Developing a New Drug

Nov 08 2010 01:30 PM | Chris Haslego in Other Topics -----

The purpose of this article is to look at how drugs are developed today in the modern world and how the chemical engineer is instrumental in the development of new drugs.  Let's first take a look at how the development of a new drug begins.  It is interesting to also know that on average it takes 12 years for an experimental drug to travel from the lab to your medicine cabinet.  Only 5 in 5,000 compounds that enter the preclinical testing phase actually make it to human testing.   One of these five drugs tested in people is approved. 

As you can see it is a rigorous and costly process that must be followed to get a new drug to your medicine cabinet.  It is estimated on average a company may spend $300 to $400 million dollars to get just one drug to your medicine cabinet.  It is not hard to see why some new medicines on the market are so expensive.  Let's take a look at the steps involved in developing a new drug.

Preclinical Testing

This is the initial phase of the testing that begins in the laboratory.  A pharmaceutical company will conduct studies in the lab and on animals to show the biological activity of the compound against a targeted disease. The compound is then evaluated for safety.  These tests take about 3 1/2 to 4 years to complete.   The chemical engineer would be heavily involved in this phase of  drug development.

Investigational New Drug Application (IND)

After the above preclinical testing is completed the company then files an IND with the FDA to begin testing the drug in people.  The IND will become effective if the FDA does not disprove it within 30 days. The IND will show results of previous experiments, how, where and by whom the new studies will be conducted.   The IND also looks at the chemical structure of the compound, how it works in the body, and any toxic effects found in the animal studies. The IND will also look at how the compound is manufactured.   The IND must be reviewed and approved by the Institutional Review Board where the study will be conducted, and progress reports on clinical trials must be submitted at least annually to the FDA.

Clinical Trials, Phase I, II, & III

After the IND has not been disapproved within 30 days, then the next phase of testing begins, which is the clinical trials.

Phase I  

This phase of the testing takes about a year and involves about 20 to 80 normal, healthy volunteers. The tests study a drug's safety profile, including the safe dosage range. The studies also determine how a drug is absorbed, distributed, metabolized and excreted, and the duration of its action. 

Phase II 

In this phase, controlled studies of approximately 100 to 300 volunteer patients (people with the disease) assess the drug's effectiveness.  This phase normally takes about 2 years.

Phase III 

This phase involves 1,000 to 3,000 patients in clinics and hospitals. Physicians monitor patients closely to determine the efficacy and identify adverse reactions. This phase lasts about three years. 

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