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The following message was posted to: PharmPK
Dear Sir,
I would like to know that when bioequivalence study is required for a
particular drug?
In fact when BE study is require and when Clinical Trial is require or
both?
Please send me the information along with the regulatory guidelines, if
available.
Many thanks & kind regards,
For, CLARIS LIFESCIENCES LIMITED
INDIA.
Sushil Kukadia
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Hi Sushil
BE studies is required for ANDA submission (Abbreviated New drug
Application). Cliniical Trials details are required for IND,NDA
submissions.
Please visit www.fda.gov/cder for regulatory guidelines.
you can download from this site.
Hope my answer is helpful to u.
Best Regards
Meera .K
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Dear Sushil,
BE study of a drug is needed when you want to market the same or
different formulation ofan already existent drug. The company first
one to market is the innovator and if you want to market after him then
you have to prove BE with this innovator product.
The DCGI guidelines also require this and for US submission, refer
www.fda.gov site
If you have any further queries do mail back.
If you want i can fwd you the FDA guidelines forBE studies
Regards
Tausif Ahmed
Doctorate student,
Dept. of Pharmaceutical Medicine
Ranbaxy Clinical Pharmacology Unit
Majeedia Hospital,
Hamdard University, New Delhi,
India
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