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Dear David and Group:
I would be grateful if you could answer the following questios:
1. Which would be the Bioequivalence Criteria when the bioequivalencia
study was performed only basedon urine samples?
2. Is there any official guideline or rule regarding this issue?
Thanks, Silvia
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The following message was posted to: PharmPK
Dear Silvia,
As per my knowledge you can use urine samples for proving
bioequivalence and the same criterias holds true for these studies
also.
You can refer to www.emea.eu.int/pdfs/human/ewp/140198en.pdf
http://www.fda.gov/cder/guidance/index.htm
With regards
Dr. Shahid Karim
Sr. Research Scientist
Dabur Research Foundation
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The following message was posted to: PharmPK
Dear Shahid:
Thanks a lot for your answer. However, you do not get a Cmax and a AUC
from
urine data. Which parameters would you compare?
Best regards, Silvia
[How about U(infinity) - db]
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Dear Silvia,
I have reviewed some articles which address your concern of which
parameters to be evaluated in case urinary data for bioequivalence. In
my view you can use (dDu/dt)max-o Tmax-ud, Ka-ud of urine data which
corresponds to Cmax, Tmax, Ka of plasma.
You can refer to this article showing bioequivalence of ranitidine.
http://www1.tums.ac.ir/daru/Daru2%202003/DR%20Sadray.PDF
Thanks and regards
Dr. Shahid Karim
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The following message was posted to: PharmPK
Dear Shahid:
Thanks a lot for your information, actually I found information in a
guideline about BE of generic products from Japan:
www.nihs.go.jp/drug/be-guide(e)/form/form-change.html
Thanks and regards, Silvia
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