Yacobi Avraham, Shah Vinod P, Bashaw Edward D, Benfeldt Eva, Davit Barbara, Ganes Derek, Ghosh Tapash, Kanfer Isadore, Kasting Gerald B, Katz Lindsey, Lionberger Robert, Lu Guang Wei, Maibach Howard I, Pershing Lynn K, Rackley Russell J, Raw Andre, Shukla Chinmay G, Thakker Kailas, Wagner Nathalie, Zovko Elizabeta, Lane Majella E
DOLE Pharma LLC, New York, New York, USA.
Pharm Res. 2014 Apr;31(4):837-46. doi: 10.1007/s11095-013-1259-1. Epub 2014 Jan 7.
This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry and regulatory agencies to discuss current regulatory issues and industry practices for establishing therapeutic bioequivalence (BE) of dermatologic topical products. The methods currently available for assessment of BE were reviewed as well as alternatives and the advantages and disadvantages of each method were considered. Guidance on quality and performance of topical products was reviewed and a framework to categorise existing and alternative methods for evaluation of BE was discussed. The outcome of the workshop emphasized both a need for greater attention to quality, possibly, via a Quality-By-Design (QBD) approach and a need to develop a "whole toolkit" approach towards the problem of determination of rate and extent in the assessment of topical bioavailability. The discussion on the BE and clinical equivalence of topical products revealed considerable concerns about the variability present in the current methodologies utilized by the industry and regulatory agencies. It was proposed that academicians, researchers, the pharmaceutical industry and regulators work together to evaluate and validate alternative methods that are based on both the underlying science and are adapted to the drug product itself instead of single "universal" method.
本文总结了近期一次研讨会的会议记录,该研讨会汇聚了来自学术界、行业和监管机构的制药科学家和皮肤科医生,旨在讨论当前的监管问题以及建立皮肤科外用产品治疗生物等效性(BE)的行业实践。对目前可用于评估生物等效性的方法以及替代方法进行了综述,并考虑了每种方法的优缺点。对外用产品的质量和性能指南进行了综述,并讨论了一个框架,用于对现有的和替代的生物等效性评估方法进行分类。研讨会的结果强调,一方面需要通过质量源于设计(QBD)方法等方式更加关注质量,另一方面需要针对外用生物利用度评估中速率和程度的测定问题开发一种“完整工具包”方法。关于外用产品生物等效性和临床等效性的讨论揭示了对行业和监管机构目前使用的方法中存在的变异性的相当大的担忧。有人提议,院士、研究人员、制药行业和监管机构应共同努力,评估和验证基于基础科学且适用于药品本身的替代方法,而不是单一的“通用”方法。