Search Results - "Pai, Sudhakar M."

Evaluation of Drug–Drug Interaction Potential of Enarodustat (JTZ‐951) Using a Cytochrome P450 Probe Cocktail by Pai, Sudhakar M., Yamada, Hiroyuki, Murata, Hiroyuki

“…The drug interaction potential of enarodustat (doses: 25, 50 mg) on the activity of cytochrome P450 (CYP) 1A2, 2C9, 2C19, 2D6, and 3A4 was evaluated after…”
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Will the Pharmacologically Meaningful Half‐Life Please Stand Up? by Chaikin, Philip, Pai, Sudhakar M.

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Evaluation of Hemoglobin Response to Treatment With Enarodustat Using Pharmacometric Approach in Japanese Anemic Patients With Chronic Kidney Disease by Naruhashi, Shinya, Fujii, Takashi, Yamada, Hiroyuki, Pai, Sudhakar M., Ninomiya, Noriko

“…Enarodustat (JTZ‐951) is a hypoxia‐inducible factor prolyl hydroxylase inhibitor that has been approved and marketed in Japan for patients with anemia with…”
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Drug Lawsuit Advertisements and the Importance of Physician Consultation Prior to Voluntary Medication Withdrawal or Transition by Moore, Kenneth T., Pai, Sudhakar M., Rogge, Mark

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Effect of the Phosphate Binder Sevelamer Carbonate on the Bioavailability of Enarodustat, an Oral Erythropoiesis Stimulating Agent by Pai, Sudhakar M., Yamada, Hiroyuki

“…Enarodustat is an orally available hypoxia‐inducible factor‐prolyl hydroxylase inhibitor which can correct the erythropoietic capacity and improve anemia in…”
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Sentinel Dosing—Time for a Risk‐Based Approach? by Bonate, Peter L., Rogge, Mark, Gries, Jean‐Michel, Prokopienko, Alexander J., Pai, Sudhakar M.

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Off‐Label Use of Ketamine: A Challenging Drug Treatment Delivery Model With an Inherently Unfavorable Risk‐Benefit Profile by Pai, Sudhakar M., Gries, Jean‐Michel

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Pharmacokinetics of Lapatinib, a Nonrenally Cleared Drug, in Patients With End‐Stage Renal Disease on Maintenance Hemodialysis by Pai, Sudhakar M., Chaikin, Philip, Berg, Jolene Kay

“…Lapatinib, a tyrosine kinase inhibitor, is approved for the treatment of breast cancer. The literature shows that it is metabolized by CYP3A4 and eliminated…”
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Hemodialysis Clearance of Enarodustat (JTZ‐951), an Oral Erythropoiesis Stimulating Agent, in Patients with End‐Stage Renal Disease by Pai, Sudhakar M., Yamada, Hiroyuki

“…The dialysis clearance of enarodustat (JTZ‐951) was determined in patients (N = 6) with end‐stage renal disease on hemodialysis. Enarodustat (5 mg PO) was…”
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Pharmacokinetics of Enarodustat in Non‐Japanese and Japanese Healthy Subjects and in Patients With End‐Stage Renal Disease on Hemodialysis by Pai, Sudhakar M., Kambhampati, Siva Rama Prasad, Naruhashi, Shinya, Yamada, Hiroyuki

“…The pharmacokinetics of enarodustat were elucidated in healthy subjects and in patients with end‐stage renal disease (ESRD) on hemodialysis in phase 1 studies…”
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Science and Evidence‐Based Review and Approval of COVID‐19 Vaccines: A Statement of Support for the US FDA by Pai, Sudhakar M., Othman, Ahmed A., Rusch, Lorraine, Masters, Joanna C., Greene, Douglas, Rogge, Mark, Gries, Jean‐Michel, Clementi, William, Kumar, Parag, Younis, Islam, Salem, Ahmed Hamed, Gaynes, Bruce I., Pastino, Gina, Derendorf, Hartmut

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Pharmacokinetics, Food Effect, Ketoconazole Interaction, and Safety of JTK‐853, a Novel Nonnucleoside HCV Polymerase Inhibitor, After Ascending Single and Multiple Doses in Healthy Subjects by Tamaki, Sekihiro, Shibata, Tsutomu, Hunt, Thomas, Gerhardt, Barbara, Yamada, Hiroyuki, Pai, Sudhakar M.

“…Pharmacokinetics, safety, and tolerability of JTK‐853, a novel HCV polymerase inhibitor, were evaluated in single and multiple ascending dose (SAD, MAD)…”
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Thorough QT/QTc Evaluation of the Cardiac Safety of Enarodustat (JTZ‐951), an Oral Erythropoiesis‐Stimulating Agent, in Healthy Adults by Pai, Sudhakar M., Yamada, Hiroyuki, Kleiman, Robert B., Zhuo, Rui, Huang, Qingtao (Mike), Koretomo, Ryosuke

“…This study evaluated the effect of enarodustat on cardiac repolarization in healthy subjects. Enarodustat (20 and 150 mg [supratherapeutic dose]), placebo, and…”
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A Mass Balance Study of 14C‐Labeled JTZ‐951 (Enarodustat), a Novel Orally Available Erythropoiesis‐Stimulating Agent, in Patients With End‐Stage Renal Disease on Hemodialysis by Pai, Sudhakar M., Connaire, Jeffrey, Yamada, Hiroyuki, Enya, Seiji, Gerhardt, Barbara, Maekawa, Michihide, Tanaka, Hiromasa, Koretomo, Ryosuke, Ishikawa, Tomohiro

“…The mass balance, pharmacokinetics, and biotransformation of JTZ‐951 (enarodustat), a novel hypoxia‐inducible factor prolyl hydroxylase inhibitor, were…”
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A Mass Balance Study of 14 C‐Labeled JTZ‐951 (Enarodustat), a Novel Orally Available Erythropoiesis‐Stimulating Agent, in Patients With End‐Stage Renal Disease on Hemodialysis by Pai, Sudhakar M., Connaire, Jeffrey, Yamada, Hiroyuki, Enya, Seiji, Gerhardt, Barbara, Maekawa, Michihide, Tanaka, Hiromasa, Koretomo, Ryosuke, Ishikawa, Tomohiro

“…The mass balance, pharmacokinetics, and biotransformation of JTZ‐951 (enarodustat), a novel hypoxia‐inducible factor prolyl hydroxylase inhibitor, were…”
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A semimechanistic model of the time‐course of release of PTH into plasma following administration of the calcilytic JTT‐305/MK‐5442 in humans by Cabal, Antonio, Mehta, Khamir, Ross, David S, Shrestha, Rajiv P, Comisar, Wendy, Denker, Andrew, Pai, Sudhakar M, Ishikawa, Tomohiro

“…ABSTRACT JTT‐305/MK‐5442 is a calcium‐sensing receptor (CaSR) allosteric antagonist being investigated for the treatment of osteoporosis. JTT‐305/MK‐5442 binds…”
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An improved LC–ESI–MS–MS method for simultaneous quantitation of rosiglitazone and N-desmethyl rosiglitazone in human plasma by O’Maille, Grace, Pai, Sudhakar M., Tao, Xiaolu, Douglas, George T., Jenkins, Rand G.

“…A fast, sensitive, and selective method for the simultaneous quantitation of rosiglitazone and N-desmethyl rosiglitazone in human plasma, using rosiglitazone-…”
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Population Pharmacodynamic Parameter Estimation from Sparse Sampling: Effect of Sigmoidicity on Parameter Estimates by Pai, Sudhakar M., Girgis, Suzette, Batra, Vijay K., Girgis, Ihab G.

“…The objective of this stimulation study was to evaluate effect of simoidicity of the concentration–effect ( C – E ) relationship on the efficiency of…”
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Pharmacodynamic parameter estimation: population size versus number of samples by Girgis, Suzette, Pai, Sudhakar M, Girgis, Ihab G, Batra, Vijay K

“…The purpose of this study was to evaluate the effects of population size, number of samples per individual, and level of interindividual variability (IIV) on…”
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Characterization of AUCs from sparsely sampled populations in toxicology studies by PAI, S. M, FETTNER, S. H, HAJIAN, G, CAYEN, M. N, BATRA, V. K

“…The objective of this work was to develop and validate blood sampling schemes for accurate AUC determination from a few samples (sparse sampling). This will…”
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