title: Establishing bioequivalence of veterinary premixes (Type A medicated articles).
abstract: 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 self-administering (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.).
authors.affiliation: Elanco Animal Health, Greenfield, IN, USA. hunterrp@lilly.com
authors.forename: R P
authors.initials: RP
authors.lastname: Hunter
authors.forename: P
authors.initials: P
authors.lastname: Lees
authors.forename: D
authors.initials: D
authors.lastname: Concordet
authors.forename: P-L
authors.initials: PL
authors.lastname: Toutain
mesh_terms: D000284:Administration, Oral; D000821:Animal Feed / Q000032:analysis*; D000818:Animals; D001315:Australia; D002170:Canada; D004335:Drug and Narcotic Control; D005062:European Union; D005503:Food Additives; D012107:Research Design / Q000592:standards; D013810:Therapeutic Equivalency; D014481:United States; D019155:Veterinary Drugs / Q000008:administration & dosage* / Q000493:pharmacokinetics*
chemical_list: D005503:Food Additives; D019155:Veterinary Drugs