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Dear Group
If a drug product has multiple strengths, for example, 15, 30 mg
doses and the bioequivalence study on the lower strength (15 mg)
proved that this strength was not equivalent when administered after
meal vs fasted. What is the relevance of conducting bioequivalence
study of a generic product of the lower strength (15 mg) vs the brand
15 mg keeping in that the brand 15 mg was not equivalent to itself.
Kind Regards
Nabil
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The following message was posted to: PharmPK
Dear Nabil,
I think in your question 2 concerns have been raised.
1.When it is recommended to have bio study on the lower strength then
usually it is done considering some safety issues involved.
2. If Reference product is not equivalent in Fed vs fasted condition
that for any generic we will be required to run both fed and fasted
state study against reference formulation and this will prove
equivalence of the generic product to the reference product in any
condition of use.
Hope I have addressed your concerns.
Regards
Manoj K. Paruthi
Manager, R&D
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The following message was posted to: PharmPK
Dear Nabil,
That "the brand 15 mg was not equivalent to itself" is not correct. What
is true, based on what I think you meant in your message, is that the
bioavailability of the brand product changes after food intake. The
generic could be found to be biequivalent to the brand after appropriate
bioequivalence studies (study design depend on the pk properties of the
drug and the type of drug product, see relative regulations of FDA or
EMEA).
Kind Regards
Konstantinos Avgoustakis, PhD
Department of Pharmacy,
University of Patras,
Rio 26500, Greece
Tel:++2610-969330
Fax: ++2610-996302
Email: avgoust.at.upatras.gr
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