筛选条件 共查询到500条结果
排序方式
Methotrexate Polyglutamates Exposure - Response Modeling in a Large Cohort of Rheumatoid Arthritis Patients Starting Methotrexate

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......

Non-Medical Switching from Tocilizumab to Sarilumab in Rheumatoid Arthritis Patients with Low Disease Activity, an Observational Study

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 ......

Queries Raised During Oncology Business Pipeline Meetings at the European Medicines Agency: A 5-Year Retrospective Analysis

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......

Contribution of Real-World Evidence in European Medicines Agency's Regulatory Decision Making

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......

Dabigatran Dosing Proposal for Adults With Atrial Fibrillation: Stress-Testing Renal Function Range in Real World Patients

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 ......

Clinical Pharmacology and Translational Considerations in the Development of CRISPR-Based Therapies

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......

SURF: A Screening Tool (for Sponsors) to Evaluate Whether Using Real-World Data to Support an Effectiveness Claim in an FDA Application Has Regulatory Feasibility

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......

Pharmacogenomic Clinical Decision Support: A Scoping Review

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......

Leveraging Clinical Pharmacology Data to Assess Biosimilarity and Interchangeability of Insulin Products

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......

共500条页码: 1/34页15条/页