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Industrial Perspective on the Benefits Realized From the FDA's Model-Informed Drug Development Paired Meeting Pilot Program.
Galluppi GR, Brar S, Caro L, Chen Y, Frey N, Grimm HP, Rudd DJ, Li CC, Magee M, Mukherjee A, Nagao L, Purohit VS, Roy A, Salem AH, Sinha V, Suleiman AA, Taskar KS, Upreti VV, Weber B, Cook J. Galluppi GR, et al. Among authors: cook j. Clin Pharmacol Ther. 2021 Nov;110(5):1172-1175. doi: 10.1002/cpt.2265. Epub 2021 May 15. Clin Pharmacol Ther. 2021. PMID: 33991429 Free PMC article. Review. No abstract available.
Why has model-informed precision dosing not yet become common clinical reality? lessons from the past and a roadmap for the future.
Darwich AS, Ogungbenro K, Vinks AA, Powell JR, Reny JL, Marsousi N, Daali Y, Fairman D, Cook J, Lesko LJ, McCune JS, Knibbe C, de Wildt SN, Leeder JS, Neely M, Zuppa AF, Vicini P, Aarons L, Johnson TN, Boiani J, Rostami-Hodjegan A. Darwich AS, et al. Among authors: cook j. Clin Pharmacol Ther. 2017 May;101(5):646-656. doi: 10.1002/cpt.659. Epub 2017 Apr 4. Clin Pharmacol Ther. 2017. PMID: 28182269 Review.
ITC Commentary on Metformin Clinical Drug-Drug Interaction Study Design That Enables an Efficacy- and Safety-Based Dose Adjustment Decision.
Zamek-Gliszczynski MJ, Chu X, Cook JA, Custodio JM, Galetin A, Giacomini KM, Lee CA, Paine MF, Ray AS, Ware JA, Wittwer MB, Zhang L; International Transporter Consortium. Zamek-Gliszczynski MJ, et al. Among authors: cook ja. Clin Pharmacol Ther. 2018 Nov;104(5):781-784. doi: 10.1002/cpt.1082. Epub 2018 May 15. Clin Pharmacol Ther. 2018. PMID: 29761830
Drug Dosing Recommendations for All Patients: A Roadmap for Change.
Powell JR, Cook J, Wang Y, Peck R, Weiner D. Powell JR, et al. Among authors: cook j. Clin Pharmacol Ther. 2021 Jan;109(1):65-72. doi: 10.1002/cpt.1923. Epub 2020 Jul 12. Clin Pharmacol Ther. 2021. PMID: 32453862 Free PMC article. Review.
6,490 results