Diaz Dorys Argelia, Colgan Stephen T, Langer Connie S, Bandi Nagesh T, Likar Michael D, Van Alstine Leslie
Worldwide Research and Development, Global Chemistry and Manufacturing Controls, Pfizer Inc, Eastern Point Road, Groton, Connecticut, 06340, USA.
Worldwide Research and Development, Global Chemistry and Manufacturing Controls, Pfizer Inc, 100 Route 206 North, Peapack, New Jersey, 07977, USA.
AAPS J. 2016 Jan;18(1):15-22. doi: 10.1208/s12248-015-9830-9. Epub 2015 Oct 1.
The objective of this article is to compare and contrast the international expectations associated with the model-independent similarity factor approach to comparing dissolution profiles. This comparison highlights globally divergent regulatory requirements to meet local dissolution similarity requirements. In effect, experiments customized to meet the current international regulatory expectations for dissolution and drug release unnecessarily increase manufacturing costs, hinder science and risk-based approaches, increase collective regulatory burden, reduce continuous improvement and innovation, and potentially delay patient access to urgently needed medication. Comparative assessment of regulatory differences in applying dissolution to demonstrate product similarity is crucial to reduce non-scientifically justified experiments and foster collaborative harmonization among global regulatory health authorities and the pharmaceutical industry.
本文的目的是比较和对比与用于比较溶出曲线的模型无关相似性因子方法相关的国际期望。这种比较凸显了为满足当地溶出相似性要求而存在的全球范围内截然不同的监管要求。实际上，为满足当前国际监管机构对溶出度和药物释放的期望而定制的实验不必要地增加了制造成本，阻碍了基于科学和风险的方法，增加了总体监管负担，减少了持续改进和创新，并可能延迟患者获得急需药物的机会。对应用溶出度来证明产品相似性方面的监管差异进行比较评估，对于减少非科学合理的实验以及促进全球监管卫生当局与制药行业之间的协同协调至关重要。
