Uncontrolled Extensions of Clinical Trials and the Use of External Controls – scoping opportunities and methods.

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Increased interest in real-world evidence (RWE) for clinical and regulatory decision making and the need to evaluate long-term benefits and risks of pharmaceutical products raise the importance of understanding the […]

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A semi-mechanistic pharmacokinetic model for depot medroxyprogesterone acetate and drug-drug interactions with antiretroviral and antituberculosis treatment.

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Depot medroxyprogesterone acetate (DMPA) is an injectable hormonal contraceptive, widely used by women of childbearing potential living with HIV and/or tuberculosis. As medroxyprogesterone acetate (MPA) is a CYP3A4 substrate, drug-drug […]

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Medication errors during treatment with new oral anticancer agents: consequences for clinical practice based on the AMBORA study.

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Patients treated with oral anticancer agents (e.g. kinase inhibitors) are a high-risk population for medication errors due to e.g. polymedication, age, and limited adherence. Systematic evaluations regarding frequencies and causes […]

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A Study of Regulatory Challenges of Paediatric Oncology Phase I/II Trial Submissions and Guidance on Protocol Development.

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The purpose of this study was to identify key deficiencies in paediatric oncology early phase clinical trial protocols in Germany and to provide guidance for efficient trial protocol development. A […]

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Association between FIASMAs and Reduced Risk of Intubation or Death in Individuals Hospitalized for Severe COVID-19: an observational multicenter study.

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Several medications commonly used for a number of medical conditions share a property of functional inhibition of acid sphingomyelinase (ASM), or FIASMA. Preclinical and clinical evidence suggest that the (ASM)/ceramide […]

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Pharmacogenetic-guided treatment of depression: real-world clinical applications, challenges and perspectives.

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Depression is a leading cause of disability worldwide and despite the availability of numerous antidepressants, the lack of standardised criteria to apply personalised prescription is still a major issue. Pharmacogenetic […]

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Assessing the Impact of FDA Breakthrough Therapy Designation Timing on Trial Characteristics and Development Speed.

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Congress created the Breakthrough Therapy designation in 2012 to expedite drug development and review through efficient clinical trial design and intensive interaction with United States (US) Food and Drug Administration […]

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Quantitative Clinical Pharmacology Supports the Bridging from IV Dosing and Approval of SC Rituximab in B-Cell Hematological Malignancies.

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A fixed-dose subcutaneous (SC) formulation of the anti-CD20 antibody, rituximab, has been developed to address safety, infusion time, and patient comfort concerns relating to intravenous (IV) dosing, and has been […]

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Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline for the use of aminoglycosides based on MT-RNR1 genotype.

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Aminoglycosides are widely used antibiotics with notable side effects such as nephrotoxicity, vestibulotoxicity and sensorineural hearing loss (cochleotoxicity). MT-RNR1 is a gene that encodes the 12s rRNA subunit and is […]

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Calibrating real-world evidence studies against randomized trials: treatment effectiveness of infliximab in Crohn’s disease.

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Real-world evidence (RWE) on the effectiveness of treatments in Crohn’s disease (CD) derived from clinical practice data will help fill many evidence gaps left by randomized controlled trials (RCTs). Emulating […]

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Exposure-Response Relationships in Patients With HER2-Positive Metastatic Breast Cancer and Other Solid Tumors Treated With Trastuzumab Deruxtecan.

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Trastuzumab deruxtecan (T-DXd) is a HER2-targeting antibody-drug conjugate composed of a novel enzyme-cleavable linker and membrane-permeable topoisomerase I inhibitor payload. T-DXd has been approved for HER2-positive metastatic breast cancer (BC) […]

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Safety, Tolerability, and Pharmacokinetics of FAAH Inhibitor BIA 10-2474: A Double-Blind, Randomised, Placebo-Controlled Study in Healthy Volunteers.

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This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of BIA 10-2474, a FAAH inhibitor, after first administration to healthy male and female subjects. Subjects (n=116) were recruited into this […]

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Cost-sharing increase, medication adherence and hospitalizations in schizophrenia patients: a natural experiment.

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Increases in medication cost-sharing rates remain a controversial system-wide cost-containment measure for chronic mental health patients. The objective was to investigate the effects of cost-sharing increases on adherence to prescribed […]

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