期刊: CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023; 114 (4)
Methotrexate polyglutamates (MTX-PG) concentrations in red blood cells (RBCs) have been suggested as a biomarker of response in patients with rheumato......
期刊: CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023; 114 (4)
Tocilizumab and sarilumab are IL-6-receptor antagonists registered for rheumatoid arthritis (RA), with equal effectiveness and safety. Switching from ......
期刊: CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023; 114 (5)
The European Medicines Agency (EMA) offers guidance and support to pharmaceutical companies through bilateral discussions called business pipeline mee......
期刊: CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023; 113 (1)
Real-world data/evidence (RWD/RWE) may provide insightful information on medicines' clinical effects to guide regulatory decisions. While its contribu......
期刊: CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023; 114 (2)
Dabigatran is the first of four direct-acting oral anticoagulants approved to prevent stroke in adult patients with atrial fibrillation using a fixed ......
期刊: CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023; 114 (3)
Genome editing holds the potential for curative treatments of human disease, however, clinical realization has proven to be a challenging journey with......
期刊: CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023; 114 (5)
Based on recent guidance and publicly available approvals, the US Food and Drug Administration (FDA) has demonstrated its openness to considering evid......
期刊: CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023; 113 (4)
Clinical decision support (CDS) is often cited as an essential part of pharmacogenomics (PGx) implementations. A multitude of strategies are available......
期刊: CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023; 113 (4)
There is over a hundred years of clinical experience with insulin for the treatment of diabetes. The US Food and Drug Administration (FDA) approved th......