Evaluation of Hemoglobin Response to Treatment With Enarodustat Using Pharmacometric Approach in Japanese Anemic Patients With Chronic Kidney Disease
Naruhashi, Shinya, Fujii, Takashi, Yamada, Hiroyuki, Pai, Sudhakar M, Ninomiya, Noriko
Published in Journal of clinical pharmacology (01.02.2023)
Published in Journal of clinical pharmacology (01.02.2023)
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Journal Article
Pharmacokinetics of Enarodustat in Non‐Japanese and Japanese Healthy Subjects and in Patients With End‐Stage Renal Disease on Hemodialysis
Pai, Sudhakar M., Kambhampati, Siva Rama Prasad, Naruhashi, Shinya, Yamada, Hiroyuki
Published in Clinical pharmacology in drug development (01.07.2023)
Published in Clinical pharmacology in drug development (01.07.2023)
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Journal Article
Science and Evidence-Based Review and Approval of COVID-19 Vaccines: A Statement of Support for the US FDA
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
Published in Journal of clinical pharmacology (01.03.2021)
Published in Journal of clinical pharmacology (01.03.2021)
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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
Tamaki, Sekihiro, Shibata, Tsutomu, Hunt, Thomas, Gerhardt, Barbara, Yamada, Hiroyuki, Pai, Sudhakar M.
Published in Clinical pharmacology in drug development (01.04.2019)
Published in Clinical pharmacology in drug development (01.04.2019)
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Journal Article
Thorough QT/QTc Evaluation of the Cardiac Safety of Enarodustat (JTZ‐951), an Oral Erythropoiesis‐Stimulating Agent, in Healthy Adults
Pai, Sudhakar M., Yamada, Hiroyuki, Kleiman, Robert B., Zhuo, Rui, Huang, Qingtao (Mike), Koretomo, Ryosuke
Published in Clinical pharmacology in drug development (01.08.2021)
Published in Clinical pharmacology in drug development (01.08.2021)
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Journal Article
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
Pai, Sudhakar M., Connaire, Jeffrey, Yamada, Hiroyuki, Enya, Seiji, Gerhardt, Barbara, Maekawa, Michihide, Tanaka, Hiromasa, Koretomo, Ryosuke, Ishikawa, Tomohiro
Published in Clinical pharmacology in drug development (01.08.2020)
Published in Clinical pharmacology in drug development (01.08.2020)
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Journal Article
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
Pai, Sudhakar M., Connaire, Jeffrey, Yamada, Hiroyuki, Enya, Seiji, Gerhardt, Barbara, Maekawa, Michihide, Tanaka, Hiromasa, Koretomo, Ryosuke, Ishikawa, Tomohiro
Published in Clinical pharmacology in drug development (01.08.2020)
Published in Clinical pharmacology in drug development (01.08.2020)
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Journal Article
A semimechanistic model of the time‐course of release of PTH into plasma following administration of the calcilytic JTT‐305/MK‐5442 in humans
Cabal, Antonio, Mehta, Khamir, Ross, David S, Shrestha, Rajiv P, Comisar, Wendy, Denker, Andrew, Pai, Sudhakar M, Ishikawa, Tomohiro
Published in Journal of bone and mineral research (01.08.2013)
Published in Journal of bone and mineral research (01.08.2013)
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Journal Article
An improved LC–ESI–MS–MS method for simultaneous quantitation of rosiglitazone and N-desmethyl rosiglitazone in human plasma
O’Maille, Grace, Pai, Sudhakar M., Tao, Xiaolu, Douglas, George T., Jenkins, Rand G.
Published in Journal of pharmaceutical and biomedical analysis (04.11.2008)
Published in Journal of pharmaceutical and biomedical analysis (04.11.2008)
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Journal Article
Pharmacodynamic parameter estimation: population size versus number of samples
Girgis, Suzette, Pai, Sudhakar M, Girgis, Ihab G, Batra, Vijay K
Published in The AAPS journal (05.10.2005)
Published in The AAPS journal (05.10.2005)
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Journal Article
Characterization of AUCs from sparsely sampled populations in toxicology studies
Pai, S M, Fettner, S H, Hajian, G, Cayen, M N, Batra, V K
Published in Pharmaceutical research (01.09.1996)
Published in Pharmaceutical research (01.09.1996)
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Journal Article
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
Pai, Sudhakar M, Connaire, Jeffrey, Yamada, Hiroyuki, Enya, Seiji, Gerhardt, Barbara, Maekawa, Michihide, Tanaka, Hiromasa, Koretomo, Ryosuke, Ishikawa, Tomohiro
Published in Clinical pharmacology in drug development (25.12.2019)
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Published in Clinical pharmacology in drug development (25.12.2019)
Journal Article
Population pharmacokinetics of temozolomide in cancer patients
JEN, J. Frank, CUTLER, David L, PAI, Sudhakar M, BATRA, Vijay K, AFFRIME, Melton B, ZAMBAS, Demetris N, HEFT, Samuel, HAJIAN, Gerald
Published in Pharmaceutical research (01.10.2000)
Published in Pharmaceutical research (01.10.2000)
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