Model‐Informed Drug Development: Connecting the Dots With a Totality of Evidence Mindset to Advance Therapeutics
Author:
Affiliation:
1. EMD Serono Research & Development Inc. Billerica MA USA
2. A Business of Merck KGaA Darmstadt Germany
3. Certara UK Canterbury UK
4. Leiden University Leiden The Netherlands
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2422
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1. Physiologically‐Based Pharmacokinetic Models for Evaluating Membrane Transporter Mediated Drug–Drug Interactions: Current Capabilities, Case Studies, Future Opportunities, and Recommendations
2. Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective
3. An Integrated Approach for Assessing the Impact of Renal Impairment on Pharmacokinetics of Drugs in Development: Pivotal Role of PBPK Modelling
4. Precision Dosing: The Clinical Pharmacology of Goldilocks
5. A Model‐Based Approach to Assess Unstable Creatinine Clearance in Critically Ill Patients
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