Supplementary Table S1 from FDA Approval Summary: Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation

Autor: Richard Pazdur, Ann T. Farrell, Kirsten B. Goldberg, Gene M. Williams, Rosane Charlab, Christopher M. Sheth, Yuan-Li Shen, Albert Deisseroth, Donna Przepiorka, Sarah E. Dorff, Ramadevi Gudi, Vicky Hsu, Lola Luo, Kelly J. Norsworthy

Preferred Terms included in grouped terms

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::477f921b3577155839505aca83b12450
https://doi.org/10.1158/1078-0432.22469378

FDA Approval Summary: Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation

Autor: Rosane Charlab, Vicky Hsu, Kelly J. Norsworthy, Ramadevi Gudi, Ann T. Farrell, Gene M. Williams, Kirsten B. Goldberg, Lola Luo, Albert Deisseroth, Sarah E. Dorff, Donna Przepiorka, Richard Pazdur, Yuan Li Shen, Christopher M. Sheth

Publikováno v: Clinical Cancer Research. 25:3205-3209

The FDA approved ivosidenib (Tibsovo; Agios), a small-molecule inhibitor of isocitrate dehydrogenase (IDH)1 on July 20, 2018, for treatment of adults with relapsed or refractory acute myeloid leukemia (R/R AML) with susceptible IDH1 mutation as detec

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6e17204f9c190b9054ed4965817d072d
https://doi.org/10.1158/1078-0432.ccr-18-3749

Predictive Performance of Physiologically-Based Pharmacokinetic Models in Predicting Drug–Drug Interactions Involving Enzyme Modulation

Autor: Vicky Hsu, Chia Hsiang Hsueh, Yuzhuo Pan, Ping Zhao

Publikováno v: Clinical Pharmacokinetics. 57:1337-1346

Physiologically-based pharmacokinetic (PBPK) modeling in predicting metabolic drug–drug interactions (mDDIs) is routinely used in drug development. Currently, the US FDA endorses the use of PBPK to potentially support dosing recommendations for inv

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::88f026f9e0647c8dc33146aba25d1d57
https://doi.org/10.1007/s40262-018-0635-8

Advancing Predictions of Tissue and Intracellular Drug Concentrations Using In Vitro, Imaging and Physiologically Based Pharmacokinetic Modeling Approaches

Autor: Daniel Tatosian, Jan Snoeys, Yingying Guo, Kim L. R. Brouwer, Jashvant D. Unadkat, Aleksandra Galetin, Neil Parrott, Swati Nagar, Vicky Hsu, Pär Matsson, Pradeep Sharma, Xiaoyan Chu, Yuichi Sugiyama, Shiew-Mei Huang

Publikováno v: Guo, Y, Chu, X, Parrott, N J, Brouwer, K L R, Hsu, V, Nagar, S, Matsson, P, Sharma, P, Snoeys, J, Sugiyama, Y, Tatosian, D, Unadkat, J D, Huang, S & Galetin, A 2018, ' Advancing Predictions of Tissue and Intracellular Drug Concentrations Using In Vitro, Imaging and Physiologically Based Pharmacokinetic Modeling Approaches ', Clinical Pharmacology & Therapeutics, vol. 104, no. 5, pp. 865-889 . https://doi.org/10.1002/cpt.1183

This white paper examines recent progress, applications, and challenges in predicting unbound and total tissue and intra/subcellular drug concentrations using in vitro and preclinical models, imaging techniques, and physiologically based pharmacokine

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::71cabdbc52037618d295344d5261c7a6
http://doi.wiley.com/10.1002/cpt.1183

The Application of Physiologically Based Pharmacokinetic Modeling to Predict the Role of Drug Transporters: Scientific and Regulatory Perspectives

Autor: Yuzhuo, Pan, Vicky, Hsu, Manuela, Grimstein, Lei, Zhang, Vikram, Arya, Vikram, Sinha, Joseph A, Grillo, Ping, Zhao

Publikováno v: Journal of clinical pharmacology. 56

Transporters play an important role in drug absorption, disposition, and drug action. The evaluation of drug transporters requires a comprehensive understanding of transporter biology and pharmacology. Physiologically based pharmacokinetic (PBPK) mod

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::3ef81be98880059cfa06be7ef4e828d6
https://pubmed.ncbi.nlm.nih.gov/27385170