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The following message was posted to: PharmPK
FDA suggests to follow "Guidance for Industry-Bioavailability and
Bioequivalence Studies for Orally Administered Drug Products" for
assessing the bioequivalence for transdermal dosage form (For e.g.
My concern here is that
1. Will TD Patches follow the same absorption (absorption phase is
there in TD Patches), elimination or distribution pattern as other
oral dosage form going through GIT and should we follow the same rules
as for oral dosage forms to assess BE?
2. Since TD patch release is affected by heat, Fat content and BMI;
should not we require some stringent BMI and tempreture criteria?
3. What are the possible design can be approached (2X2, Reference
Scaled ABE, 3X3 Replicated, Placebo arm in bioequivalence)?
4. Clearly I want to ask that the BE design for TD patches will follow
the same criteria or it will have some different designing approaches?
Thanks in advance for your suggestions
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