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Clinical Trials are medical research studies that are regulated by the United States Government, Food and Drug Administration (FDA) to test the safety and effectiveness of any pharmaceutical drug before it reaches the consumer.
Three phases of the clinical trials must be completed to the satisfaction of the FDA before New Drug Approval (NDA) can be granted.
Phase I Defined
Phase I clinical trials are where the drug is tested for safety (adverse effects), dosage tolerance, absorption, metabolism, distribution, excretion and pharmacodynamics.
Phase II Defined
Phase II clinical trials involve studies in a limited patient population to
- evaluate the efficacy of the drug for specific, targeted indications,
- determine the dosage tolerance and optimal dosage and
- identify possible adverse effects and safety risks.
Phase III Defined
Phase III clinical trials further evaluate clinical efficacy and test further for safety within an expanded patient population and at multiple clinical sites.
New Drug Approval Defined
Information/Documents are submitted to the Food and Drug Administration in support of a drug which would permit the marketing of the drug that is the subject of the application. The FDA will approve an application and issue an approval letter if it determines that the drug meets the statutory standards for safety, effectiveness, manufacturing, and controls for labeling.
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