Optimizing the Dosing Regimen of Cetuximab and Ramucirumab Using the Model‐Informed Drug Development Paradigm

Model‐informed drug development (MIDD) is a process that integrates drug exposure‐based, biological, and statistical models to enhance the benefit–risk balance in drug development. The US Food and Drug Administration (FDA) MIDD Paired Meeting Pilot Program provides a platform to apply MIDD approache...

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Bibliographic Details
Published in:	Clinical pharmacology and therapeutics Vol. 114; no. 1; pp. 77 - 87
Main Authors:	Ni, Lan, Khan, Azhar Zaman, Long, Amanda, Gao, Ling, Toms, Nikki, Gonzalez‐Gugel, Elena, Holsmer‐Brand, Susan, Lin, Yong, Abada, Paolo, Dickin, Sandra, O'Dea, Declan, Wei, Ran, Jen, Min‐Hua, Aggarwal, Himani
Format:	Journal Article
Language:	English
Published:	United States 01-07-2023
Subjects:	Antibodies, Monoclonal, Humanized Cetuximab Drug Development Humans Pharmaceutical Preparations Ramucirumab
Online Access:	Get full text
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Summary:	Model‐informed drug development (MIDD) is a process that integrates drug exposure‐based, biological, and statistical models to enhance the benefit–risk balance in drug development. The US Food and Drug Administration (FDA) MIDD Paired Meeting Pilot Program provides a platform to apply MIDD approaches to drug development and to seek regulatory feedback in a collaborative and streamlined process prior to submission for approval. Eli Lilly and Company (Lilly) participated in the Pilot Program to seek agency alignment to enhance the initial approved dosing regimens of cetuximab (Erbitux; Eli Lilly and Company, Indianapolis, IN) and ramucirumab (Cyramza; Eli Lilly and Company) without conducting additional clinical trials. Here, we describe the overall MIDD strategy at Lilly, the process with the FDA, and the impact of implementing the approach.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-3 content type line 23 ObjectType-Review-1
ISSN:	0009-9236 1532-6535
DOI:	10.1002/cpt.2919