Comparison of bioequivalence study regulatory requirements for human and veterinary drugs.
Guidelines published by the European Union Regulatory Authority, regarding the planning of bioequivalence studies, are the primary source of knowledge about the study design optimization. The goal of this paper is to compare the key elements (27 points) of bioequivalence study optimization based on a comparison of the two European Medicines Agency guidelines relating to medicines used for humans (HB) and to veterinary drugs (AB). In case of the latter, one can get the impression that the issues of species differences in relation to the physiology and anatomy have been completely ignored. Many details that the AB guideline omits are included in the new HB guideline and were present in many other guidelines from the last 20 years. Most have not been adopted by the AB document, even though they are the product of many years of work of many teams and specialists from various agencies in the regulatory affairs field.
Polpharma Biologics ul. Trzy Lipy 3, 80-172 Gdańsk, Poland. tomasz.grabowski@polpharma.com
Tomasz
T
Grabowski
Monika
M
Marczak
Jerzy Jan
JJ
Jaroszewski
Monica
M
Whitmire
D000818:Animals; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D004364:Pharmaceutical Preparations / Q000378:metabolism; D010599:Pharmacokinetics; D013810:Therapeutic Equivalency; D019155:Veterinary Drugs / Q000493:pharmacokinetics*
D004364:Pharmaceutical Preparations; D019155:Veterinary Drugs