Bioequivalence and Bioavailability Forum

Dear All,

As per WHO notes, As the EoI includes two strengths, 125 and 250 mg (scored) dispersible tablets, the highest strength should be used in the bioequivalence study if the conditions for a biowaiver for the low strength are fulfilled. Otherwise, both strengths should be tested.

https://extranet.who.int/prequal/sites/default/files/document_files/BE_Amoxicillin_March2025.pdf

As per FDA, one fasting study is sufficient with higher strength 250 mg/5 mL Amoxicillin suspension.
https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050460.pdf

for Canada, how many studies should be conducted?

Amoxicillin suspension 250 mg/5 mL (reference product dose 5mL) versus 250 mg/5 mL (Test product dose 5mL) BE in fasting condition is sufficient to take the BE Waiver for 125 mg/5 mL strength?

Amoxicillin suspension 250 mg/5 mL (reference product dose 5mL) versus 125 mg/5 mL (Test product dose 10mL) BE in fasting condition should be done?

Amoxicillin suspension 250 mg/5 mL (reference product dose 5mL) versus 250 mg/5 mL (Test product dose 5mL) BE in fasting condition and Amoxicillin suspension 125 mg/5 mL (reference product dose 5mL) versus 125 mg/5 mL (Test product dose 5mL) BE in fasting condition two independent studies to be conducted?

There is no specific guidance available for Amoxicillin suspension BE studies for Canada.

Please suggest, Thanks in advance.

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Edit: Category changed; see also this post #1. [Helmut]