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The following message was posted to: PharmPK
Dear All,
With regard to antineoplastic agents and anti-immune drugs is it
possible to
go for waiver rather than conducting a BE study for the generics as
it is
not possible or ethical to do the BE study on healthy subjects. I'm
interested to know about the possibility for waiver for the following
drugs:
1. azathioprine
2. Imatinib mesylate
3. Tacrolimus
4. Thalidomide
Your help is greatly appreciated
Thanks
Raja' Sammour
QA Supervisor/Triumpharma
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Dear Raja,
The BA and BE studies of the cytotoxic agents are done
only on the diseased person. You can not take any trial on the
healthy human voluenteres. You can refer for the guidelines available
on the FDA site (www.fda.gov).
Thanks
Tushar Nahata
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Dear Raja
FDA itself has given OGD recommendations for doing BA/BE studies in
healthy human volunteers and already some pharma companies are in the
process of doing this BA/BE study with atmost precautions as per the
STEPS programme.
Regarding Tacrolimus many pharma cos have done studies in healthy
human volunteers and no major AE was observed
Hope this will help you.
regards
Ramu
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The following message was posted to: PharmPK
Dear Raja,
For Tacrolimus, you can get waiver (fasting as well as fed study) for
lower strengths if your different strengths are proportionally similar
(for proportional similarity criterion of FDA see general guidelines
on BA/BE). Although if lower strengths are not proportionally similar,
still there is possibility that you might get waiver for lower
strengths on the basis of dissolution similarity but you should
consult the FDA generic drugs office directly. Only they can give you
in writing. For Fed study if your dissolution profiles are similar
then you need to conduct biostudy on highest strength only i.e. 5 mg
(see guidelines for fed BA/BE studies).
In fact the above mentioned criterion are applicable to any drug with
multiple strengths.
Regards,
Sukhbir Singh
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The following message was posted to: PharmPK
Dear Raja,
Rama's statement about tacrolimus is correct.
> [...]
>
> FDA itself has given OGD recommendations for doing BA/BE studies in
> healthy human volunteers [...]
See this link:
http://www.fda.gov/cder/guidance/bioequivalence/recommendations/
Tacrolimus_cap_50708_RC7-06.pdf
Best regards,
Helmut
--
Ing. Helmut Schuetz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna, Austria
e-mail helmut.schuetz.-a-.bebac.at
web http://bebac.at
forum http://forum.bebac.at
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