Chamberlain Paul
NDA Advisory Services, Ltd, Grove House, Guildford Road, Leatherhead, Surrey KT22 9DF, UK.
Bioanalysis. 2019 Sep;11(17):1581-1592. doi: 10.4155/bio-2018-0209. Epub 2019 Feb 15.
The purpose of this article is to provide practical advice about how to present immunogenicity-related information in regulatory dossiers, with a particular focus on a model for an Integrated Summary of Immunogenicity to be submitted in the marketing authorization application for novel biopharmaceutical products in ICH regions (EU, USA and Japan). A format that links the analysis of potential risk factors to a justification of the methodology applied for risk evaluation and conclusions for risk mitigation is presented as a model that can be adapted according to the weight of evidence to be submitted in support of the assessment of impact on overall clinical benefit versus risk for the particular situation.
本文旨在提供有关如何在监管文件中呈现免疫原性相关信息的实用建议，特别关注一种免疫原性综合摘要模型，该模型将提交至人用药品注册技术协调会（ICH）地区（欧盟、美国和日本）新型生物制药产品上市许可申请中。一种将潜在风险因素分析与风险评估所用方法的合理性及风险缓解结论相联系的格式，作为一种模型呈现出来，可根据为支持特定情况下对总体临床获益与风险影响评估而提交的证据权重进行调整。
