Pierard I, Spelte G, Le Tallec D, Duchêne M
GlaxoSmithKline Biologicals, Rixensart, Belgium.
Biologicals. 2009 Nov;37(6):403-6; discussion 421-3. doi: 10.1016/j.biologicals.2009.08.011. Epub 2009 Oct 22.
Stability studies represent a significant workload for both manufacturers and regulatory reviewers and therefore a careful selection of the study design and of the stability indicator test is required to make sure that the study will provide the relevant information. Moreover, alternatives to the existing regulatory approaches should be favoured in order to better or quicker analyze the impact of a specific change. In this article, examples of alternative approaches are given. For the stability monitoring study, emphasis is put on the bulk stability program. Concerning comparability stability study, two case studies illustrating how accelerated stability studies could be used to support manufacturing changes are presented.
稳定性研究对制造商和监管审评人员而言都是一项繁重的工作，因此需要谨慎选择研究设计和稳定性指标测试，以确保研究能提供相关信息。此外，应优先采用现有监管方法的替代方法，以便更好或更快地分析特定变更的影响。本文给出了替代方法的示例。对于稳定性监测研究，重点在于原料药稳定性计划。关于可比性稳定性研究，本文介绍了两个案例研究，说明如何利用加速稳定性研究来支持生产变更。
