British Journal of Clinical Pharmacology, Volume 92, Issue 11, Page 3703-3706, November 2026.
Jakša Vukojević +3 more
wiley +1 more source
Contribution of cytochrome P450-mediated metabolism to clavulanic acid-induced cytotoxicity in TK6-derived cytochrome P450-overexpressing cell lines. [PDF]
Fang JL, Li X, Chen S, Beland FA.
europepmc +1 more source
Advances in New Approach Methodologies at FDA's Division of Applied Regulatory Science
New Approach Methodologies (NAMs) represent a paradigm shift in drug development and regulatory science, offering human‐relevant alternatives to traditional preclinical models. This mini‐review highlights recent advances in NAM development, validation, and regulatory application from FDA's Division of Applied Regulatory Science (DARS).
Ksenia Blinova +9 more
wiley +1 more source
Drug-Drug Interactions Between Oral Anticoagulants and Calcineurin Inhibitors in Nephrotic Syndrome for Management of Thromboembolism. [PDF]
Hirai T, Katayama K.
europepmc +1 more source
From Prediction to Decision Making: PBPK and QSP as Regulatory‐Grade NAMs
New approach methodologies (NAMs) encompass a diverse and rapidly evolving set of experimental and computational tools designed to generate human‐relevant mechanistic data for use in drug development and regulatory decision making. Experimental NAMs provide insights into drug disposition, pharmacological activity, and disease biology that are difficult
Karen Rowland Yeo, Piet H. van der Graaf
wiley +1 more source
Pharmacokinetics and Safety Evaluation of the Transglutaminase 2 Inhibitor Suvigletistat in Healthy Chinese, Japanese, and White/European Participants. [PDF]
Nand RA +5 more
europepmc +1 more source
ABSTRACT In recent years the addition of the oral BCL2 inhibitor venetoclax to hypomethylating agents (HMAs) has emerged as the standard‐of‐care for patients with acute myeloid leukemia (AML) who are not fit for intensive chemotherapy, significantly improving survival and quality‐of‐life.
Mariarita Sciumè +9 more
wiley +1 more source
Pharmacogenetic, Clinical, Prescribing, and Demographic Predictors of Sertraline Pharmacokinetics. [PDF]
de la Cruz CG +8 more
europepmc +1 more source
ABSTRACT We aimed to evaluate the association between IL10 variants and plasma IL‐10 levels and clinical outcomes in patients with severe COVID‐19 treated with corticosteroids. We studied 944 patients with severe COVID‐19 who were treated with corticosteroids.
Ingrid Fricke‐Galindo +12 more
wiley +1 more source
Pharmacokinetic Drug-Drug Interactions of Imlunestrant in Healthy Female Participants of Nonchildbearing Potential. [PDF]
Datta-Mannan A +5 more
europepmc +1 more source

