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Dear Group,
If we have a drug product of two components, can we waive the
biostudy according to its individual BCS.
If one component is biowaived and another does not, can we perform
the biostudy for one component and not for other to save the money of
two component analysis?
Beit Jala Pharmaceutical Co.
Dr. Kholoud Al-Emam
Registration Supervisor
Tel: +962 6 565 0300
Fax: +962 6 565 0307
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Dear Dr Kholoud,
I think we need to consider the drug product of two
components as a new formulation and perform the biostudy to
evaluate both the components separately.
Regards,
Dr Suhas
Principal Investigator
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The following message was posted to: PharmPK
Dear Kholoud Al-Emam,
I'm really not sure, however I suspect you need a confirmation of non-
existence of DDI (drug-drug interactions).
As far as I know, for a two component product, if combi is not
already marketed, it's enough to demonstrate combo vs. single
components bioequivalence a the required dose level.
This means that for a two components combo it is enough a crossover 3
arms study of bioequivalence: component 1, component 2 and combo.
You can find other answers in http://www.fda.gov/oc/combination/
I hope this is helpful
Best regards
Stefano Porzio
Inpharzam Ricerche S.A. - Zambongroup
Taverne
Switzerland
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