?

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 or -
?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 total -
daily dose exceeds that specified in the approved labeling; or
A multiple-dose study in normal subjects or patients where either the single or total daily dose -
exceeds that specified in the approved labeling; or
A multiple-dose study on an extended release product on which no single-dose study has -
been completed
Will the person conducting the study retain reserve samples of any test article and reference
standard used in the study and release the reserve samples to FDA upon request and
?consistent with other FDA requirements described below
Will the study be conducted consistent with the requirements of 21 C.F.R. part 50 (human
?(subjects protections) and part 56 (IRB requirements
If the formulation of the test article is the
same as the formulation(s) used in the
clinical studies demonstrating substantial
evidence of safety and effectiveness for
the test article's claimed indications, a
reserve sample of the test article used to
conduct an in vivo bioavailability study
comparing the test article to a reference
.oral solution, suspension, or injection
If the formulation of the test article differs
from the formulation(s) used in the clinical
studies demonstrating substantial evidence
of safety and effectiveness for the test
article's claimed indications, a reserve
sample of the test article and of the
reference standard used to conduct an in
vivo bioequivalence study comparing the
test article to the formulation(s) (reference
.standard) used in the clinical studies
,For a new formulation, new dosage form
or a new salt or ester of an active drug
ingredient or therapeutic moiety that has
been approved for marketing, a reserve
sample of the test article and of the
reference standard used to conduct an in
vivo bioequivalence study comparing the
test article to a marketed product
reference standard) that contains the)
same active drug ingredient or
.therapeutic moiety
N
.Y An IND is required
.Y An IND is required
N
.N An IND is required
YN
.N An IND is required
.Y No IND is required
Note: additional exceptions exist for research on
§ .radiopharmaceuticals in some instances. See 21 C.F.R
Contact MICHR or the Health System Legal Office .361.1

for 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 and
.available 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
How much drug is absorbed•
 How quickly the drug is absorbed•
How much of the absorbed drug remains free and available•
.Bioavailability is different for different drugs
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