Establishing bioequivalence of veterinary premixes (Type A medicated articles)
Résumé
a) Key issues concerning Premix (Type A medicated articles) Bioequivalence
evaluations:
1) This is a complex issue concerning both route of administration and
formulation.
2) If the animal is not at the bunk ⁄ trough, the animal is not selfadministering
(eating medicated feed), thus there can be no drug
absorption.
b) Differing opinions among scientists and regulatory authorities ⁄ expert
bodies regarding:
1) No harmonization on how to design, conduct, and interpret in vivo studies.
2) Applicability of biowaivers to Type A (premix) products.
3) Why are topdress and complete feed considered differently? Are they
different formulations or different routes of administration?
4) Single dose vs. multi-dose studies.
5) What is the final formulation?
c) What are the next steps:
1) Harmonize current bioequivalence guidelines through the VICH process.
2) Determine the applicability ⁄ non-applicability of the Biopharmaceutical
Classification System (BCS).
3) Establish the Total Mixed Ration (i.e. formulation) effects.
4) Define the test subject (individual, pen, etc.).
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JVPT - PLT -establishing bioeq - 2012_{54942D64-5BC5-4C0E-902D-A90E07E4A836}.pdf (184.4 Ko)
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