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Biotech / Medical : CNSI Cambridge Neuroscience
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To: cur who wrote (259)9/22/1997 4:00:00 PM
From: Apple Jacks   of 675
 
This may help. It has been obtained from a variety of sources.

Briefly, the steps required for drug approval in the United States are:

Pre-Clinical Animal Studies: Pre-clinical studies primarily involve evaluations of toxic effects and pharmacokinetics and metabolism of a drug in animals, to provide evidence of the safety of the drug prior to its administration in humans in clinical studies. A typical program of preclinical studies takes an average of 18 to 24 months to complete. The results of the pre-clinical studies as well as the comprehensive descriptions of proposed human clinical studies are then submitted as part of the IND to the FDA. This is necessary (in the United States) prior to undertaking clinical studies.

Phase I Clinical Trials: Phase I clinical trials take an average of one year to complete and are conducted on a small number of healthy human subjects to evaluate the drug's pharmacological actions, toxicity, metabolism and pharmacokinetics.

Phase II Clinical Trials: Phase II clinical trials take an average of two years to complete and are carried out on a relatively small number of patients suffering from the targeted disease or medical condition to determine the drug's effectiveness and dose response relationship. This phase also provides additional safety data and serves to identity possible common short-term side effects and risks in a larger group of patients.

Phase III Clinical Trials: Phase III clinical trials take an average of three years to complete and involve tests on a much larger population of patients suffering from the targeted condition or disease. These studies involve conducting controlled testing and/or uncontrolled testing in an expanded patient population (several hundred to several thousand patients) at geographically dispersed test sites (multi-center trials) to establish clinical safety and effectiveness. These trials also generate information from which the overall benefit-risk relationship relating to the drug can be determined and provide a basis for drug labeling.

Upon completion of Phase III clinical studies, the pharmaceutical company sponsoring the new drug then assembles all the pre-clinical and clinical data and submits it to the FDA as part of a New Drug Application ("NDA") in the United States. The submission or application is then reviewed by the regulatory body for approval to market the product.

Phase IV Clinical Trials: This final phase involves monitoring the long-term efficacy and risks (side effects) of a drug after it has entered the market. These studies also measure the drug's efficacy and safety.

The average length of completion time given can vary substantially depending on the disease, the dosage form, drug half-life etc.

Hope it was informative!
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