摘要
近一年来,我国药政管理部门要求对已经上市的药物开展一致性评价研究,并制定了通过一致性评价的年限,逾期没有通过一致性评价的品种将不得再生产。面对这一新的要求,制药企业需要尽快开展有关品种的一致性评价工作。本文结合有关文献资料、作者个人的经验,对一致性评价研究中涉及的有关问题进行了探讨,在一致性评价研究中强调了对涉及的预BE(生物等效性)、IVIVC(体内、外相关性)、PBPK(基于生理模型的药代动力学)等技术的应用,提出了仿制药一致性评价研究策略。期望对制药企业开展一致性评价研究有所帮助。
In the nearly passed one year, the regulatory agent of China required the pharmaceutical enterprises to carry out the similarity assessment on their marketed products, and set up deadline for the end of similarity assessment. After the deadline, the failed products and the products without similarity assessment will not be given market authorization. To meet these new requirements, pharmaceutical enterprises need to initiate similarity assessment of their products as soon as possible. In present paper, based on the published articles and author＇s personal experiences, we investigated the problems related to the similarity assessment, and we emphasized the applications of techniques such as informal bioequivalent studies, in vitro and in vivo correlation（IVIVC）, and physiological based pharrnacokinetics（PBPK）. Strategies were proposed for the studies of similarity assessment. We wish the present information be useful to pharmaceutical enterorises.
