Analysis of an eligible protocol for bioequivalence testing of two Canine anthelmintics products with two active molecules

  • Diana Denisa TODORAN Faculty of Veterinary Medicine, University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca, Calea Mănăștur 3-5, Cluj-Napoca, 400372
  • Melania CRIȘAN Faculty of Veterinary Medicine, University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca, Calea Mănăștur 3-5, Cluj-Napoca, 400372
  • Octavia TAMAS-KRUMPE Faculty of Veterinary Medicine, University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca, Calea Mănăștur 3-5, Cluj-Napoca, 400372
  • Daria FENESAN Faculty of Veterinary Medicine, University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca, Calea Mănăștur 3-5, Cluj-Napoca, 400372
  • Doru NECULA Country Centre of Mountain Economy “CE-MONT”, INCE, Romanian Academy, Petreni Street, no. 49, 725700, Vatra Dornei, Romania
  • Laurențiu OGNEAN Faculty of Veterinary Medicine, University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca, Calea Mănăștur 3-5, Cluj-Napoca, 400372
Keywords: bioequivalence, Siberian Husky, study design

Abstract

This study is intended to analyze the design implemented in the bioequivalence testing of a generic product based on praziquantel and milbemycin oxime. The main objective of the study is to develop a protocol suitable for testing the bioequivalence and bioavailability of a new generic anthelmintic product intended for the therapeutic interchange of the innovative product Milbemax, whose patent has expired. The achievement of the proposed objective was ensured by the implementation of a single-center, cross-over, randomized, two-phase design separated by a break of 30 days between them. The current study was conducted on 22 clinically healthy Siberian Husky dogs. The analysis of the values obtained during the monitoring of the clinical and hematologic parameters, revealed evolutions within the allowed ranges, with the deviations being rare and devoid of clinical or statistical significance. Providing information regarding the field of bioequivalence of two similar antiparasitic products, being aware of the regulations in force as well as their recommendation by the treating veterinarian, in prophylaxis and anthelmintic therapy, is a good strategy to promote the use and acceptance of the new generic drugs.

Published
2024-05-15