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ASEAN GUIDELINE FOR THE CONDUCT OF BIOEQUIVALENCE …

criteria under which bioavailability studies need not be required (either waiver for additional strength, see section 3.1.6, a specific type of formulation, see Appendix II or BCS based Biowaiver, see Appendix III). Specific recommendations regarding bioequivalence studies for other products, eg.

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  Studies, Bioavailability, Bioavailability studies

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