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The following message was posted to: PharmPK
Dear all,
Does anyone has any prior experience of conducting a
bioequivalence study on Carvedilol?
My area of concern is - - should I apply BE criteria only
to carvedilol or its metabolites also?
Literature tells that one of the metabolites is more active
than the parent drug and other metabolites are also active.
I could find three references on published BE study on
Carvedilol and all them applied BE criteria to the parent
drug only.
Pl let me know should I consider only parent drug?
If metabolites are required, which of them?
Regards,
Suhas
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Dear Suhas,
USFDA recommends measuring both, the parent drug as well as the
metabolite 4-hydroxyphenyl-carvedilol. However, bioequivalence is to
be established only with the parent drug.
Hope this helps.
Cordially,
Dr. Renu Jain
Research Associate
Clinical Research & Regulatory Affairs
Torrent Research Centre
Village:Bhat; Dist:Gandhinagar
Phone: 079 - 2396 9100 Ext.: 607
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Dear Suhas,
Information provided by Dr. Renu is correct. Good luck with your study.
Thanks
Manoj K. Paruthi
Sr. Manager, R&D
Hikma Pharmaceuticals Plc.
Amman, Jordan
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The following message was posted to: PharmPK
Dear Suhas,
As per USFDA BE criteria, one needs to estimate the metabolite if it is
major metabolite (>10% of the parent). Moreover, the Cmax of metabolite
is less sensitive to difference in rate of absorption than Cmax of the
parent drug.
With regard to carvedilol, BE criteria is applied to parent drug only.
Hope this helps.
Regards
Dr. Tausif Ahmed
Metabolism and Pharmacokinetics Dept.
Ranbxy Research lab.
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Dear Renu,
Is that applies for every drug??
Dr. Mandar Mote
> renujain.-a-.torrentpharma.com wrote:
> USFDA recommends measuring both, the parent drug as well as the
> metabolite 4-hydroxyphenyl-carvedilol. However, bioequivalence is to
> be established only with the parent drug.
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Dear Suhas,
According to Brazilian Regulations (ANVISA), only the parent drug has
to be measured in a bioequivalence study. Metabolite 4-hydroxyphenyl-
carvedilol can be measured as well, but the data will be applied only
as a support. The bioequivalence has to be established with the
parent drug.
Cordially,
Paula Macedo Cerqueira, PhD
Wissen Consultants
Sao Paulo - Brazil
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The following message was posted to: PharmPK
As per Fda requirement we require to analyse both parent and
metabolite but
CI applies to only parent compd. Metabolite data is supportive.
Pankaj Gupta
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Dear Dr. Mote,
no, it does not apply to every drug...
for eg. for venlafaxine, BE is to be established for both, the parent
drug and the metabolite ODV
Cordially,
Dr. Renu Jain
Research Associate
Clinical Research & Regulatory Affairs
Torrent Research Centre
Village:Bhat; Dist:Gandhinagar
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