Acceso abierto

The Statistical Analysis of Pharmacokinetic Parameters in the Context of Bioequivalence Testing of Two Anthelmintic Formulas Based on Ivermectine and Triclabendazole in Sheep


Cite

1. Barrera B, Otero JA, Egido E et al. The Anthelmintic Triclabendazole and Its Metabolites Inhibit the Membrane Transporter ABCG2/BCRP. Antimicrob Agents Chemother 2012; 56(7): 3535-3543.10.1128/AAC.06345-11339342622508302Search in Google Scholar

2. Halferty L, Brennan GP, Trudgett A, Hoey L, Fairweather I. Relative activity of triclabendazole metabolites against the liver fluke, Fasciola hepatica. Vet Parasitol 2009; 159:126–138.10.1016/j.vetpar.2008.10.00719027238Search in Google Scholar

3. González Canga A, Sahagún Prieto AM, José Diez Liébana M, Martínez NF, Vega MS, Vieitez JJ. The pharmacokinetics and metabolism of ivermectin in domestic animal species. Vet J 2009; 179: 25–37.10.1016/j.tvjl.2007.07.01117851096Search in Google Scholar

4. Lifschitz A, Virkel G, Ballent M, Sallovitz J, Lanusse C. Combined use of ivermectin and triclabendazole in sheep: In vitroand in vivo characterisation of their pharmacological interaction. Vet J 2009; 182: 261–268.10.1016/j.tvjl.2008.06.00118640064Search in Google Scholar

5. Stevenson CR, Mahoney RH, Fisara P, Strehlau G, Reichel MP. The efficacy of formulations of triclabendazole and ivermectin in combination against liver fluke (Fasciolahepatica) and gastro-intestinal nematodes in cattle andsheep and sucking lice species in cattle. Aust Vet J. 2002; 80(11): 698-70110.1111/j.1751-0813.2002.tb11303.x12465830Search in Google Scholar

6. International Committee for Harmonization. GUIDELINE FOR GOOD CLINICAL PRACTICE E6 (R1). https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf [retrieved March 22nd 2019]Search in Google Scholar

7. The European Agency for the Evaluation of Medicinal Products. CVMP Guideline on the Conduct of Bioequivalence Studies for Veterinary Medicinal Products, EMA/CVMP/016/00-Rev.2.Search in Google Scholar

8. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-conduct-bioequivalence-studies-veterinary-medicinal-products-revision-2_en.pdf [retrieved March 22nd 2019]Search in Google Scholar

9. The European Agency for the Evaluation of Medicinal Products. CVMP Guidelines for the Conduct of Bioequivalence Studies for Veterinary Medicinal Products, EMEA/CVMP/016/00-corr-FINAL.Search in Google Scholar

10. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-conduct-bioequivalence-studies-veterinary-medicinal-products-revision-1_en.pdf [retrieved March 22nd 2019]Search in Google Scholar

11. The European Agency for the Evaluation of Medicinal Products. VICH GL52 Bioequivalence: Blood Level Bioequivalence Study, EMA/CMVP/VICH/751935/2013-Corr. https://www.ema.europa.eu/en/documents/scientific-guideline/international-cooperation-harmonisation-technical-requirements-registration-veterinary-medicinal_en-3.pdf [retrieved March 22nd 2019]Search in Google Scholar

12. http://kineticadownload.com/Kinetica5.0/data/Kinetica%20User%20Manual.pdf [retrieved March 22nd 2019]Search in Google Scholar

13. U.S. Department of Health and Human Services, Food and Drug Administration, Bioavailability and Bioequivalence Studies for Orally Administrated Drug Products – General Considerations, Rockville, USA, 2003, https://www.fda.gov/downloads/Drugs/Guidances/ucm154838 [retrieved March 22nd 2019]Search in Google Scholar

14. The European Agency for the Evaluation of Medicinal Products. Note for Guidance on the Investigation of Bioavailability and Bioequivalence, London, UK, 2001 (CPMP/EWP/QWP/1401/98). https://www.ema.europa.eu/en/documents/scientific-guideline/draft-note-guidance-investigation-bioavailability-bioequivalence_en.pdf [retrieved March 22nd 2019]Search in Google Scholar

15. The European Agency for the Evaluation of Medicinal Products. Guideline on bioanalytical method validation (EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2). https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf [retrieved March 22nd 2019]Search in Google Scholar

16. U.S. Department of Health and Human Services, Food and Drug Administration. Bioanalytical Method ValidationGuidance for Industry. https://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf [retrieved March 22nd 2019]Search in Google Scholar

eISSN:
2247-6113
Idioma:
Inglés
Calendario de la edición:
6 veces al año
Temas de la revista:
Medicine, Clinical Medicine, other