Part 312 - Investigational New Drug Application Flashcards
The clinical investigation of a drug product thay is lawfully marketed in the US is exempt.from the requirements of IND if all the following apply
1) the investigation is not intended to be reported to the FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling of the drug
2) if the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support any other significant change in the labeling for the drug
3) investigation does not involve route of administration or dosage level or use in a patient population or other factor that significantly increases the risks associated with the use of the drug product
4) complies with requirements for Institutional Review and with the requirements for informed consent
5)
Includes initial introduction of an investigational new drug into humans. Used to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and (if possible) to gain early evidence on effectiveness. Sufficient info about pharmacological effects and pharmokinetics should be obtained to permit the design of good phase ? Studies.
Include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans.
Number of subjects vary but are usually 20-80.
Phase 1 study
Clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine common short-term side effects and risks associated with the drug.
Typically well-controlled, closely monitored, and co ducted with no more than several hundred subjects.
Phase 2 studies
Expanded controlled & uncontrolled trials
Performed after preliminary evidence suggesting effectiveness of the drug have been obtained, and are intended to gather the additional info about effectiveness and safety that is needed to evaluate overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.
Usually include several hundred-several thousand subjects.
Phase 3 studies
In all phases: To assure the safety and rights of subjects
In phase 2 & 3: help assure the quality of the scientific evaluation of drugs is adequate to permit an evaluation of the drugs effectiveness and safety
FDAs primary objective in reviewing IND
Meeting used to review and reach agreement on the design of animal studies needed to initiate human testing
Pre-investigational new drug (IND) meetings
Meetings to review and reach agreement ok the design of phase 2 clinical trials
End-of-phase 1 meetings
Studies to delineate additional information about the drug’s risk, benefit, & optimal use
Postmarketing (phase 4) studies
