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The following message was posted to: PharmPK
Hi,
When a patent of a drug expires we can conduct BE studies and produce
a generic version of the drug for tablets, capsules etc. In case of
Parenterals the drug is directly released into blood. So, BE studies
cannot help in producing Generic Verision of Parenterals. So, what are
the requirements (tests to be conducted) to produce a generic version
of Parenterals.
Regards,
ChandraSekhar
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There is no need to perform BE study for the IV parenterals as the
bioavailability of such products is 100 % and there is no need to
compare with any standard product. Here we have to perform chemical
and pharmaceutical equivalency only. Some time we may have to perform
toxicity study also (it will depend on the type of drug) But for
complicated NDDS IV formulations we have to perform not only chemical
and pharmaceutical equivalency but also we have to perform so many
toxicity and animal stucies to prove equivalency of our product.
Regards,
Tushar Nahata
Deptt of Pharmacy
SGSITS,Indore (MP) India
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The following message was posted to: PharmPK
Chandu,
Just a correction: BE studies for tablets, capsules etc can be done
also
before expiration of US patent - sometimes called the "Bolar" amendment;
also see paragraph IV certification of the Hatch Waxman Act.
Sri
Srikumaran Melethil, Ph.D., J.D.
Chair, Department of Pharmaceutical Sciences
Patent Attorney
School of Pharmacy
The University of Findlay
1000 N. Main Street
Findlay, OH 45840
800-452-7502 (x 4440)
Direct line: 419-434-4440
Fax: 419-434-4390
Email: melethil.aaa.findlay.edu
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