Drug Trial


If the FDA Approves the IND Application, the Drug May Then Be Employed in Initial Human Clinical Trials Clinical Study:

Phase 1 - The initial cautious trial involving a relatively small number of normal humans. Trial is usually short (I to 6 months) where the drug's biological activity and effects on target or gans are determined (e.g., kidney, liver, bone marrow, and heart).

 Phase 2 - More detailed observations of drug effects on normal volunteers, as well as the initial testing on diseased patients. Dosage range is established. Critical observations of the disease process are made in relationship of the new drug candidate. In addition, long-term chronic toxicity studies on laboratory are initiated.

Phase 3 - Broad clinical trials designed to determine whether the drug is of clinical benefit in the disease state or syndrome. Hospital-university specialists are recruited to work along with company physicians and scientists in this expanded phase. Final dosage forms are established. Risk/benefit ratio is assessed, if possible. Long-term chronic toxicity studies with lab animals in Phase 2 are reviewed and provide a basis on which to study the drug's effect on reproduction and fertility; additional animal studies are conducted to determine the drug's potential to induce cancer or other abnormalities in the fetus. If the drug has use in children or the elderly, Phase 3 study must also include safety and effectiveness determinations at various ages.

Phase 4 Trials: Post-marketing clinical trials begin to test the long-term effects of the newly-approved drug. Usually a new drug is scrutinized closely for I to 2 years after approval but, in effect, all drugs are continuously monitored by the FDA for many years.

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