Is PBPK useful to inform product label on managing clinically significant drug interactions mediated by cytokine release syndrome?
Author:
Affiliation:
1. Quantitative Clinical Pharmacology Daiichi Sankyo, Inc. Basking Ridge New Jersey USA
2. Bill & Melinda Gates Foundation Seattle Washington USA
Publisher
Wiley
Link
https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.13185
Reference13 articles.
1. Evaluating drug interaction potential from cytokine release syndrome using a physiologically based pharmacokinetic model: A case study of teclistamab
2. Physiologically Based Pharmacokinetic Model to Assess the Influence of Blinatumomab‐Mediated Cytokine Elevations on Cytochrome P450 Enzyme Activity
3. Assessment of CYP3A‐mediated drug interaction via cytokine (IL‐6) elevation for mosunetuzumab using physiologically‐based pharmacokinetic modeling
4. Evaluation of the potential impact on pharmacokinetics of various cytochrome P450 substrates of increasing IL‐6 levels following administration of the T‐cell bispecific engager glofitamab
5. FDA.NDA 125557 Blinatumomab clinical pharmacology and biopharmaceutics review(s).2014. Available from:https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125557Orig1s000ClinPharmRedt.pdf
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