Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Oral Ivosidenib in Otherwise Healthy Participants-Reference-Cited by-同舟云学术

Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Oral Ivosidenib in Otherwise Healthy Participants

Published:2020-07-09 Issue:1 Volume:10 Page:99-109
ISSN:2160-763X
Container-title:Clinical Pharmacology in Drug Development
language:en
Short-container-title:Clinical Pharmacology in Drug Development

Author:

Fan Bin¹,Dai David¹,Cohen Marvin²,Xu Huansheng¹,Yin Feng¹,Nagaraja Raj¹,Mobilia Michelle¹,Almon Caroline¹,Basile Frank G.¹,Yang Hua¹

Affiliation:

1. Agios Pharmaceuticals Inc. Cambridge Massachusetts USA

2. MBC Pharma Solutions Newtown Pennsylvania USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmaceutical Science

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpdd.821

Reference12 articles.

1. Durable Remissions with Ivosidenib inIDH1-Mutated Relapsed or Refractory AML

2. Ivosidenib induces deep durable remissions in patients with newly diagnosed IDH1-mutant acute myeloid leukemia

3. Effect of itraconazole, food, and ethnic origin on the pharmacokinetics of ivosidenib in healthy subjects

4. Clinical pharmacokinetics and pharmacodynamics of ivosidenib, an oral, targeted inhibitor of mutant IDH1, in patients with advanced solid tumors

5. Ivosidenib: First Global Approval

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3. A review of the evidence base for utilizing Child-Pugh criteria for guiding dosing of anticancer drugs in patients with cancer and liver impairment;ESMO Open;2021-06

4. Population pharmacokinetic and exposure‐response analyses of ivosidenib in patients with IDH1 ‐mutant advanced hematologic malignancies;Clinical and Translational Science;2021-01-25