Model-informed drug development approach supporting approval of the 4-week (Q4W) dosing schedule for nivolumab (Opdivo) across multiple indications: a regulatory perspective

Bi, Y; Liu, J; Furmanski, B; Zhao, H; Yu, J; Osgood, C; Ward, A; Keegan, P; Booth, BP; Rahman, A; Wang, Y

Model-informed drug development approach supporting approval of the 4-week (Q4W) dosing schedule for nivolumab (Opdivo) across multiple indications: a regulatory perspective

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posted on 2024-09-20, 02:09 authored by Y Bi, J Liu, B Furmanski, H Zhao, J Yu, C Osgood, A Ward, P Keegan, BP Booth, A Rahman, Y Wang

Model-informed drug development approach supporting approval of the 4-week (Q4W) dosing schedule for nivolumab (Opdivo) across multiple indications: a regulatory perspective

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DOI - Is version of https://doi.org/10.1093/annonc/mdz037

Location

England

Language

English

Publication classification

C1.1 Refereed article in a scholarly journal

Journal

ANNALS OF ONCOLOGY

Volume

30

Pagination

644-651

ISSN

0923-7534

eISSN

1569-8041

Issue

4

Publisher

OXFORD UNIV PRESS

Publication URL

http://dx.doi.org/10.1093/annonc/mdz037

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Keywords

Science & Technology Life Sciences & Biomedicine Oncology nivolumab Q4W dosing frequency model-informed drug development immuno-oncology clinical pharmacology regulatory perspective PROGRESSION CANCER

Model-informed drug development approach supporting approval of the 4-week (Q4W) dosing schedule for nivolumab (Opdivo) across multiple indications: a regulatory perspective

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