Description
This guidance is intended to harmonize the data recommendations associated within vivoblood level bioequivalence (BE) for veterinary pharmaceutical products. To meet this objective, the guidance addresses the following topics:
Scope & Applicability
Product Classes
10The scope of the guidance covers these products
dosage form designed to be applied to intact skin for systemic absorption
veterinary medicinal product intended for oral administration following its incorporation into animal feedstuffs
rate and/or place of release of the API(s) is different from that of an immediate release dosage form
dosage form that is deliberately modified to protract the release rate
Products compared against reference products in BE studies
The comparator product in a bioequivalence study
product selection in BE studies supporting approval
intended for repeated dosing
Orally administered formulations for non-ruminants
Stakeholders
2Body that recommended the guideline for consultation
The number of subjects provided in the table (N)
Regulatory Context
Attributes
10Area under the curve extrapolated to infinity
Variability limit of not more than 15% for qualification
Sample size estimates based upon within subject variability
Translates into as a 90% confidence interval (2α = 0.10)
concentration of the API in the blood increases proportionally with the increasing dose
Biological property that may be altered by manufacturing changes; safety narrative should address bioavailability of the ingredients
The feeding status of the subjects during the study; Feeding status of animals during the study
if it can be substantiated that the reference product exhibits linear PK
reference products with less than proportional increase in AUC
duration should be at least 5 times the blood terminal elimination half-life
See Also (8)
- CVM GFI #13 Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds-Medicated Block
- CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species
- CVM GFI #234 Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications
- CVM GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209
- CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices
- FDA's Strategy on Antimicrobial Resistance - Questions and Answers
- CVM GFI #5 Drug Stability Guidelines
- CVM GFI #142 (VICH GL29) Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)