Bioequivalence and Bioavailability Forum

Dear ElMaestro,

FDA Guidance Topical Dermatological Corticosteroids-In vivo bioequivalence (Issue Date: 2 June 1995) has a section on vasoconstrictor assay which explains about validation and standardization (linearity, accuracy, precision and sensitivity). We recently received an RFI from a EU regulatory body asking whether the vasoconstrictor bioassay complies with the EU bioanalytical guideline.

Kind regards,
Tina

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]