Rangaraj Narayanan
Celgene
5 Papers
10 Citations
Rangaraj Narayanan is an academic researcher from Celgene. The author has contributed to research in topics: Physiologically based pharmacokinetic modelling & Population. The author has an hindex of 4, co-authored 5 publications.
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Papers
Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective.
Mohamad Shebley,Punam Sandhu,Arian Emami Riedmaier,Masoud Jamei,Rangaraj Narayanan,Aarti Patel,Sheila Annie Peters,Venkatesh Pilla Reddy,Ming Zheng,Loeckie de Zwart,Maud Beneton,Francois Bouzom,Jun Chen,Yuan Chen,Yumi Cleary,Christiane Collins,Gemma L. Dickinson,Nassim Djebli,Heidi J. Einolf,Iain Gardner,Felix Huth,Faraz Kazmi,Feras Khalil,Jing Lin,Aleksandrs Odinecs,Chirag Patel,Haojing Rong,Edgar Schuck,Pradeep Sharma,Shu Pei Wu,Yang Xu,Shinji Yamazaki,Kenta Yoshida,Malcolm Rowland +33 more
TL;DR: This work provides a perspective on the qualification and verification of physiologically based pharmacokinetic (PBPK) platforms/models intended for regulatory submission based on the collective experience of the Simcyp Consortium members.
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The Uremic Toxin Indoxyl-3-Sulfate Induces CYP1A2 In Primary Human Hepatocytes
TL;DR: Results suggest that the uremic toxin, 3-INDS, is a potent CYP1A2 inducer and lends valuable mechanistic basis for how kidney disease can affect hepatic metabolism.
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Assessment of drug-drug interaction potential and PBPK modeling of CC-223, a potent inhibitor of the mammalian target of rapamycin kinase.
Zeen Tong,Rangaraj Narayanan,Christian Atsriku,Jim Nissel,Yan Li,Hong Liu,Xiaomin Wang,Sekhar Surapaneni +7 more
TL;DR: Model based predictions of DDI with ketoconazole were in agreement with observed results enabling prospective predictions of DDIs between CC-223 and CYP3A4 inhibitors, and PBPK model of CC- 223 and M1 was developed and verified using clinical results.
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Application of a "Fit for Purpose" PBPK Model to Investigate the CYP3A4 Induction Potential of Enzalutamide
TL;DR: A "fit for purpose" PBPK model of enzalutamide was developed and successfully developed using public information that recapitulated it's observed pharmacokinetics, CYP3A4 induction potential and the potential need for dose-adjustment of co-administered CYP2A4 substrates.
Evaluation of a New Molecular Entity as a Victim of Metabolic Drug-Drug Interactions - an Industry Perspective
Tonika Bohnert,Aarti Patel,Ian Templeton,Yuan Chen,Chuang Lu,W. George Lai,Louis Leung,Susanna Tse,Heidi J. Einolf,Ying-Hong Wang,Michael Sinz,Ralph Stearns,Robert L. Walsky,Wanping Geng,Sirimas Sudsakorn,David Moore,Ling He,Jan Wahlstrom,Jim Keirns,Rangaraj Narayanan,Dieter Lang,Xiaoqing Yang +21 more
TL;DR: Multiple decision trees are presented with stepwise approaches to identify specific enzymes that are involved in the metabolism of a given drug and to aid the prediction and risk assessment of drug as a victim in DDI to better predict DDI risk in humans.