Proceedings of a Workshop: US Food and Drug Administration-International Society of Pharmacometrics Model-Informed Drug Development in Oncology

Clin Pharmacol Ther. 2019 Jul;106(1):81-83. doi: 10.1002/cpt.1421. Epub 2019 Apr 5.

Authors

Rene Bruno¹, Jin Y Jin², Kimberly Maxfield³, Lauren Milligan³, Chao Liu³, Yaning Wang³, Amy E McKee³, Issam Zineh³

Affiliations

¹ ISoP and Genentech/Roche, Clinical Pharmacology, Marseille, France.
² ISoP and Genentech/Roche, Clinical Pharmacology, South San Francisco, California, USA.
³ US Food and Drug Administration, Silver Spring, Maryland, USA.

PMID: 30951201
DOI: 10.1002/cpt.1421

No abstract available

Publication types

Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

MeSH terms

Drug Development / organization & administration*
Drug Evaluation, Preclinical / methods
Endpoint Determination
Humans
Models, Statistical
Prescription Drugs / adverse effects
Prescription Drugs / pharmacokinetics
Prescription Drugs / pharmacology*
Prescription Drugs / therapeutic use*
Product Surveillance, Postmarketing
Research Design
United States
United States Food and Drug Administration / organization & administration*

Substances

Prescription Drugs