Establishing bioequivalence of veterinary premixes (Type A medicated articles)

Robert Hunter (1) , Peter Lees (2) , Didier Concordet (3) , Pierre-Louis Toutain (3)

1 Elanco Animal Health
2 Royal Veterinary College
3 ToxAlim - ToxAlim

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.).

Mots clés: PHENYLBUTAZONE; BIOAVAILABILITY; FOOD; ABSORPTION; FORMULATION; DISSOLUTION; BIOPHARMACEUTICS CLASSIFICATION-SYSTEM; IN-VITRO; PRODUCT BIOEQUIVALENCE; HIGHLY VARIABLE DRUGS

Domaines: Sciences du Vivant [q-bio]

Robert Hunter, Peter Lees, Didier Concordet, Pierre-Louis Toutain. Establishing bioequivalence of veterinary premixes (Type A medicated articles). Journal of Veterinary Pharmacology and Therapeutics, 2012, 35 (1), pp.53-63. ⟨10.1111/j.1365-2885.2012.01368.x⟩. ⟨hal-01191254⟩