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Bioequivalence accomplishments, ongoing initiatives, and remaining challenges.
1US Food and Drug Administration, Center for Veterinary Medicine, Rockville, MD, USA.
Journal of Veterinary Pharmacology and Therapeutics
|July 12, 2013
Summary
Assessing veterinary product bioequivalence (BE) faces unique challenges. This review updates advancements and initiatives for veterinary BE, highlighting methods for complex dosage forms and species-specific needs.
Area of Science:
- Veterinary Pharmacology
- Drug Product Comparability
- Bioequivalence Studies
Background:
- Bioequivalence (BE) assessment concepts originated in the late 1960s.
- Significant advancements in tools for product comparability assessment have occurred.
- Unresolved challenges persist in bioequivalence evaluations.
Purpose of the Study:
- To provide an update on recent advances in veterinary bioequivalence.
- To highlight achievements and ongoing initiatives in veterinary product assessment.
- To address challenges unique to veterinary medicine in bioequivalence.
Main Methods:
- Review of recent advancements in bioequivalence assessment tools.
- Discussion of unique challenges in veterinary medicine (e.g., multiple species, dosage forms).
- Exploration of methods for evaluating long-acting veterinary products.
Main Results:
- Veterinary bioequivalence faces unique hurdles including diverse species, dosage forms (intramammary, premixes), and physiological constraints.
- Adaptation of human health advancements is sometimes possible, but novel methods are often required.
- Progress has been made in addressing these specific veterinary challenges.
Conclusions:
- Continued innovation is necessary to overcome unique veterinary bioequivalence challenges.
- Developing tailored methods is crucial for ensuring product equivalence in veterinary medicine.
- This review summarizes key developments and ongoing efforts in the field.
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