Proceedings of a Workshop: US Food and Drug Administration‐International Society of Pharmacometrics Model‐Informed Drug Development in Oncology-Reference-Cited by-同舟云学术

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

Published:2019-04-05 Issue:1 Volume:106 Page:81-83
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Bruno Rene¹,Jin Jin Y.²,Maxfield Kimberly³,Milligan Lauren³,Liu Chao³,Wang Yaning³,McKee Amy E.³,Zineh Issam³

Affiliation:

1. ISoP and Genentech/RocheClinical Pharmacology Marseille France

2. ISoP and Genentech/RocheClinical Pharmacology South San Francisco California USA

3. US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1421

Reference5 articles.

1. Section I of the PDUFA VI Performance Goals Ensuring the Effectiveness of the Human Drug Review part J Enhancing Regulatory Decision Tools to Support Drug Development and Review.

2. Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation

3. Clinical Pharmacology and the Catalysis of Regulatory Science: Opportunities for the Advancement of Drug Development and Evaluation

4. US Food and Drug Administration.FDA‐ISoP Public Workshop: Model Informed Drug Development (MIDD) for Oncology Products.

5. Learning versus confirming in clinical drug development*

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