Overcoming regulatory challenges in the development of companion diagnostics for monitoring and safety-Reference-Cited by-同舟云学术

Overcoming regulatory challenges in the development of companion diagnostics for monitoring and safety

Published:2016-03 Issue:2 Volume:13 Page:155-167
ISSN:1741-0541
Container-title:Personalized Medicine
language:en
Short-container-title:Personalized Medicine

Author:

Shimazawa Rumiko¹²,Ikeda Masayuki³

Affiliation:

1. Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

2. Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan

3. Department of Medical Informatics, Kagawa University Hospital, Miki-cho Ikenobe, Kagawa 761-0793, Japan

Abstract

Concurrent development and co-approval of a companion diagnostic (CDx) with a corresponding drug is ideal, but often unfeasible. Because of limited exposure to a drug in clinical trials, crucial information on safety is sometimes revealed only after approval. Therefore, a CDx for monitoring/safety is often developed after approval of a corresponding drug. However, regulatory guidance is insufficient if contemporaneous development is not possible, thereby leaving plenty of opportunities for improvement with respect to pharmacovigilance and retrospective validation of the CDx. Furthermore, global harmonization of guidance on how to incorporate new scientific information from retrospective analyses of biomarkers should lead to the establishment of more evidence for the development of CDx for approved drugs.

Publisher

Future Medicine Ltd

Subject

Pharmacology,Molecular Medicine,General Medicine

Link

https://www.futuremedicine.com/doi/pdf/10.2217/pme.15.51

Reference80 articles.

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