Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 27 that when the effect of food administration involves changes in gastrointestinal physiology such as fluid volume, motility, pH, and bile salts, the food effects were generally predictable. A decision tree was formulated based upon the analysis to guide the categorization of application of PBPK models of food ef- fects into those of high, medium, and low confidence (7). Such categorization will be helpful in the interpretation of PBPK food effect models as well as in identifying areas where additional research is needed (i.e., those models considered moderate and low confidence). Conclusion PBPK modeling has been established as an important predictive science in pharmaceutical drug development over the past two decades; the aforementioned case studies from the IQ Consor- tium demonstrate the significant progress that the industry is making toward enabling 'virtual' human experiments and streamlining drug development. References 1. C. Perry, et al., Curr Pharmacol Rep 6 71–84 (2020). 2. M. Jamei, G. L. Dickinson, A. Rostami-Hodjegan, Drug Metab Pharmacokinet 24 (1) 53–75 (2009). 3. L. Kuepfer L, et al., CPT Pharmacometrics Syst Pharmacol 5 (10) 516–531 (2016). 4. M. Shebley, et al., Clin Pharmacol Ther 104 (1) 88-110 (2018). 5. M. Jamei, et al., Expert Opinion on Drug Metabolism & Toxicology 5 (2) 211–223 (2009). 6. N. Miller, et al., Clinical Pharmacokinetics 58 (6) 727–746 (June 2019). 7. A.E. Riedmaier, et al., AAPS J 22(6) 123 (2020). 8. H.M. Jones, et al., Clin Pharmacol Ther 97 (3) 247–262 (2015). 9. H.J. Einolf, et al., Clin Pharmacol. Ther.95 (2) 179–188 (2014). 10. M.L. Vieira, et al., Clin Pharmacol Ther 95 (2) 189–198 (2014). 11. FDA, In Vitro Drug Interaction Studies — Cytochrome P450 En- zyme- and Transporter-Mediated Drug Interactions Guidance for In- dustry (CDER, January 2020). 12. I.E. Templeton, et al., CPT Pharmacometrics Syst. Pharmacol 5 (10) 505–515 (2016). 13. Y. Chen, et al., CPT Pharmacometrics Syst. Pharmacol 8 (9) 685–695 (2019). 14. O.A. Fahmi, et al., Drug Metab Dispos 44 (10) 1720–1730 (2016). 15. T. Heimbach, et al., Clin Pharmacol Ther in press. PT About the authors Heidi J. Einolf is director, modeling and simulation, pharma- cokinetic sciences, Novartis; Stephen D. Hall is senior research fellow, drug disposition, and Tracy Williams is senior director ADME/Toxicology/PKPD, both with Eli Lilly and Co; Aarti Patel is director, DMPK modeling, GlaxoSmithKline; Christo- pher Gibson is distinguished scientist and Nancy G.B. Agrawal is vice-president, pharmacokinetics, pharmacodynamics, and drug metabolism, both with Merck; and Jens Sydor,*, is vice-president, DMPK, GlaxoSmithKline; all authors are members of the IQ Consortium. *To whom all correspondence should be addressed. Connect with Sign up for our eNewsletters Get the latest news, research, and trends in the pharmaceutical industry delivered straight to your inbox by signing up. pharmaceutical-technology Follow us PharmTech_social_Ads_072120.indd 1 PharmTech_social_Ads_072120.indd 1 7/21/20 10:28 AM 7/21/20 10:28 AM

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