Draft Note Guidance Investigation Bioavailability ...
21 bioavailability or bioequivalence studies are necessary and to formulate requirements for their 22 design, conduct, and evaluation. The possibility of using in vitro instead of in vivo studies 23 with pharmacokinetic end points is also envisaged. 24 This guideline should be read in conjunction with Directive 75-318/EEC, as amended, and
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