兽用化学药品血药浓度法生物等效性试验注册资料技术评审要点及常见问题

Technology Evaluation Points and Common Problems for Registration Data of Bioequivalence Test of Veterinary Chemical Drugs by Plasma Concentration Method

关键词:  兽用化学药品  血药浓度法  生物等效性试验  评审要点  常见问题

Key words:  veterinary chemical drug  plasma concentration method  bioequivalence test  evaluation points  common problem

摘要:

生物等效性试验作为兽药获批上市的关键试验,其研究过程和技术评审都要遵循特定的法规和指导原则。以药动学参数为终点的血药浓度法生物等效性试验是目前普遍采用的研究方法,适用于药物活性成分吸收进入体循环具有全身作用的剂型(大多数内服剂型和特殊注射剂)。本文根据生物等效性定义、相关法规和指导原则,结合近年来兽药注册资料,对血药浓度法生物等效性试验的技术评审要点及常见问题进行梳理,旨在为新兽药的研发和注册提供参考。

Abstract:

As a key test for veterinary drug to be approved for marketing, the bioequivalence test should comply with specific regulations and guidelines in its research process and technical evaluation. The bioequivalence test of plasma concentration method with pharmacokinetic parameters as the end point is widely used to the research, which is applicable to the dosage forms (most oral dosage forms and special injections) with systemic effects when the active ingredients of drugs are absorbed into the systemic circulation. According to the definition of bioequivalence, relevant regulations and guiding principles, and in combination with the registration data of veterinary generic drugs in the recent years, this paper sorts out the technology evaluation points and common problems of the blood drug bioequivalence test, aiming to provide reference for the research, development and registration of new veterinary drugs.