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Has anyone ever heard of the FDA requesting a bioequivalence study for
an iv formulation?
Thanks,
pete
Peter L. Bonate, PhD
Director, Pharmacokinetics
ILEX Oncology, Inc
4545 Horizon Hill Blvd
San Antonio, TX 78229
email: pbonate.aaa.ilexonc.com
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Typically, BE STudies are not required if an IV solution. However,
certain complexe solution may require BE due to potential release
problems (e.g. Paclitaxel due to cremophor, depot).
It is the same for oral products; suspensions require BE study but not
oral solution which can be approved only based on in vitro data.
Eric Masson, Pharm.D.
Senior Director, Scientific and Regulatory Affairs
Anapharm Inc.
2050 boul. Rene-Levesque W,
Quebec, QC, Canada G1V 2K8
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21 CFR Ch 1, 320.22 Criteria for waiver of evidence of in vivo
bioavailability ... :
FDA shall waive the requirement ... if ... bioequivalence may be
considered
self-evident... (as for a) ... drug product that is a parenteral
solution
intended solely for administration by injection, ...
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Dear Peter,
In case of generic IV formulations, the inactives should also be same
as that of RLD so that potential BE problems are not anticipated. Same
holds true for Oral solutions, opthalmics etc. If there is a change in
excipients, which may contribute to BE problem (for example
surfactants) FDA may ask for a BE study.
Sunil V
Lupin Research Park
Pune, India.
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Yes. Glaxo had to do an IV bioequivalence study with Remifentanil for
two different routes of synthesis. The two routes appeared to produce
slightly different tox profiles (turned out to be just chance). The
measured content of remifentanil was identical in both products but it
was determined that we should do an IV BE study. The two products were
shown to be bioequivalent.
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Dear Dr. Keith,
Well its an unique example that u were determined to do a IV
bioequivalence.Just i want to clarify whether FDA specifically asked
you to do so or u have done it on your own.
Generally, if the API differs in the impuriy profiling and inturn the
toxicities( may be because of the different route of synthesis ), an
applicant need to qualify those impurities and establish that impurity
levels are substantially safe. This is documented somewhere in the
BACPAC also.Its quite surprising that FDA demands for the IV
bioequivalence.
Anyway thanks for the valuable information.
Regards,
Pradeep S. Bhadauria
Research Scientist
Ranbaxy Research Laboratories
India.
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