Application of physiologically based pharmacokinetic (PBPK) modeling to support dose selection: Report of an FDA public workshop on PBPK

CPT: Pharmacometrics and Systems Pharmacology

Volumn 4, Issue 4, 2015, Pages 226-230

  Wagner, C ^a   Zhao, P ^a   Pan, Y ^a   Hsu, V ^a   Grillo, J ^a   Huang, S M ^a   Sinha, V ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOCHROME P450 2D6; CYTOCHROME P450 3A; IBRUTINIB;

ARTICLE; CLINICAL PHARMACOLOGY; CONSENSUS; DECISION MAKING; DRUG EFFICACY; DRUG EXPOSURE; DRUG INDUSTRY; DRUG LEGISLATION; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; MATHEMATICAL MODEL; PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELING; PREDICTION; PRIORITY JOURNAL; SCIENTIST; STUDY DESIGN; UNITED STATES; WORKSHOP;

EID: 84936751860     PISSN: None     EISSN: 21638306     Source Type: Journal    
DOI: 10.1002/psp4.33     Document Type: Article

References (7)

1. Federal Register: FDA Public Workshop "Application of Physiologically-Based Pharmacokinetic Modeling to Support Dose Selection." < https://www.federalregister.gov/articles/2014/02/11/2014-02883/application-of-physiologically-based-pharmacokinetic-modeling-to-support-dose-selection-notice-of > (2014).
2. 2014 FDA Public Workshop: Application of Physiologically-Based Pharmacokinetic Modeling to Support Dose Selection. < http://www.fda.gov/Drugs/NewsEvents/ucm387698.htm > (2014). Accessed on 27 October 2014.
3. Wagner, C., et al,. Predicting the effect of cytochrome P450 inhibitors on substrate drugs: analysis of physiologically based pharmacokinetic modeling submissions to the US Food and Drug Administration. Clin. Pharmacokinet. 54, 117-127 (2015).
4. Vieira, MD., et al,. PBPK model describes the effects of comedication and genetic polymorphism on systemic exposure of drugs that undergo multiple clearance pathways. Clin. Pharmacol. Ther. 95, 550-557 (2014).
5. Ibrutinib Clinical Pharmacology and Biopharmaceutics Review. < http://www.accessdata.fda.gov/drugsatfda-docs/nda/2013/205552Orig1s000ClinPharmR.pdf > (2013). Accessed on 2 February 2014.
6. Jones, H., et al,. Physiologically based pharmacokinetic modeling in drug discovery and development: a pharmaceutical industry perspective. Clin. Pharmacol. Ther. 97, 247-262 (2015).
7. Zhao, P., Rowland, M., &, Huang, S.M., Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions. Clin. Pharmacol. Ther. 92, 17-20 (2012).