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Is an Investigational New Drug (IND) Application Needed?Bioavailability or Bioequivalence Studies

Does the drug:-contain a “new chemical entity” or -does the study involve a radioactively labeled drug product

-Does the study involve a cytotoxic drug product?Is the study:-A single-dose study in normal subjects or patients where either the maximum single or totaldaily dose exceeds that specified in the approved labeling;

-A multiple-dose study in normal subjects or patients where either the single or total daily doseexceeds that specified in the approved labeling;

-A multiple-dose study on an extended release product on which no single-dose study hasbeen completedWill the person conducting the study retain reserve samples of any test article and referencestandard used in the study and release the reserve samples to FDA upon request andconsistent with other FDA requirements described below?Will the study be conducted consistent with the requirements of 21 C.F.R. part 50 (humansubjects protections) and part 56 (IRB requirements?(If the formulation of the test article is thesame as the formulation(s) used in theclinical studies demonstrating substantialevidence of safety and effectiveness for the test article's claimed indications, areserve sample of the test article used toconduct an in vivo bioavailability studycomparing the test article to a referenceoral solution, suspension, or injection.If the formulation of the test article differsfrom the formulation(s) used in the clinicalstudies demonstrating substantial evidenceof safety and effectiveness for the testarticle's claimed indications, a reservesample of the test article and of thereference standard used to conduct an invivo bioequivalence study comparing thetest article to the formulation(s) (referencestandard) used in the clinical studies.For a new formulation, new dosage form,or a new salt or ester of an active drugingredient or therapeutic moiety that hasbeen approved for marketing, a reservesample of the test article and of thereference standard used to conduct an invivo bioequivalence study comparing thetest article to a marketed product)reference standard) that contains thesame active drug ingredient or therapeutic moiety.NY An IND is required.Y An IND is required.NN An IND is required.Y NN An IND is required.Y No IND is required.

Note: additional exceptions exist for research onradiopharmaceuticals in some instances. See 21 C.F.R§ .361.1.Contact MICHR or the Health System Legal Officefor assistance.

Bioavailability refers to the maximum amount of a drug that is absorbed into the body, and how quickly that maximum amount becomes available to the body. No drug has perfect bioavailability, so taking 25mg of Drug X does not mean that 25mg of that drug is actually absorbed from the stomach/intestines into the rest of the body andavailable to cause the desired action.Once a drug is absorbed, not all of the absorbed drug remains free and active in the body.Some is immediately broken down, and some is bound to other molecules (and thus"unavailable" to cause its treatment effect.(Bioavailability is a measure of all of these things:

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How much drug is absorbed