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The following message was posted to: PharmPK
Dear alls:
Could anyone say me if, are there bioequivalence studies using animals?
What is the design for this type of studies?
Thank you very much,
Fanny Cuesta
Departamento de Farmacología y Toxicología
Universidad de Antioquia
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The following message was posted to: PharmPK
Dear Fanny Cuesta
Yes, bioequivalence studies are routinely conducted in animals,
particularly
in support of the registration of generic drug formulations. The
recommended
study design is a two-way crossover with a minimum of six animals in
each
group.
Hope this helps.
Ronette Gehring
Ronette Gehring, BVSc MMedVet (Pharm)
Research Assistant Professor of Pharmacology
Food Animal Residue Avoidance Databank
Center for Chemical Toxicology Research and Pharmacokinetics
College of Veterinary Medicine
North Carolina State University
Raleigh
NC 27606
Tel: (919) 513-6803
Fax: (919) 513-6358
888-USFARAD (FARAD)
E-mail: Ronette_Gehring.at.ncsu.edu
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The following message was posted to: PharmPK
The FDA has a guidance for bioequivalence studies to support generic
veterinary drug products. Similar to human pharmaceuticals, subject
number
should be based upon study design (parallel versus crossover),
variability
estimate (within-subject for crossover, between subject for parallel
studies), and anticipated differences between means. Generally, this
necessitates the inclusion of approximately 10 - 12 subjects per
sequence
(crossover).
Parallel study designs are used for very long half-life drugs (e.g.,
implants), studies in rapidly growing animals, or species where there is
very limited blood volume. As with human pharmaceuticals, crossover is
the
preferable design.
For more information, refer to
http://www.fda.gov/cvm/guidance/bioequivalence%20Oct02.doc
Marilyn Martinez, Ph.D;
CVM/FDA
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