Role of Physiologically Based Pharmacokinetic Modeling and Simulation in Enabling Model‐Informed Development of Drugs and Biotherapeutics-Reference-Cited by-同舟云学术

Role of Physiologically Based Pharmacokinetic Modeling and Simulation in Enabling Model‐Informed Development of Drugs and Biotherapeutics

Published:2020-11 Issue:S1 Volume:60 Page:
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Arya Vikram¹^ORCID,Venkatakrishnan Karthik²^ORCID

Affiliation:

1. Division of Infectious Disease Pharmacology (DIDP), Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland USA

2. EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany) Billerica Massachusetts USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.1770

Reference41 articles.

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

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3. Utilization of physiologically based pharmacokinetic modeling in clinical pharmacology and therapeutics: an overview;Perry C;Curr Pharmacol Rep

4. Physiologically Based Pharmacokinetics as a Component of Model‐Informed Drug Development: Where We Were, Where We Are, and Where We Are Heading

5. Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration’s Office of Clinical Pharmacology

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