Opportunities and challenges for applying model‐informed drug development approaches to gene therapies-Reference-Cited by-同舟云学术

Opportunities and challenges for applying model‐informed drug development approaches to gene therapies

Published:2021-03-05 Issue:4 Volume:10 Page:286-290
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacometrics Syst. Pharmacol.

Author:

Belov Artur¹,Schultz Kimberly²,Forshee Richard¹,Tegenge Million A.¹²³

Affiliation:

1. Office of Biostatistics & Epidemiology Center for Biologics Evaluation and Research US Food and Drug Administration (FDA) Silver Spring Maryland USA

2. Office of Tissues and Advanced Therapies Center for Biologics Evaluation and Research US Food and Drug Administration (FDA) Silver Spring Maryland USA

3. Office of Tissues and Advanced Therapies, Division of Clinical Evaluation and Pharmacology/Toxicology Center for Biologics Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Modelling and Simulation

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.12597

Reference28 articles.

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2. A Holistic and Integrative Approach for Advancing Model‐Informed Drug Development

3. Model‐Informed Drug Development: Current US Regulatory Practice and Future Considerations

4. Model-Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives

5. Clinical Pharmacology Review of Plasma‐derived and Recombinant Protein Products: CBER Experience and Perspectives on Model‐Informed Drug Development

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