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Clinical Trials, Phase I as Topic

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Ultra-sensitive LC-MS/MS method for the quantification of gemcitabine and its metabolite 2',2'-difluorodeoxyuridine in human plasma for a microdose clinical trial.

Journal of pharmaceutical and biomedical analysis
In microdose clinical trials a maximum of 100 μg of drug substance is administered to participants, in order to determine the pharmacokinetic properties of the agents. Measuring low plasma concentrations after administration of a microdose is challen...

On strategic choices faced by large pharmaceutical laboratories and their effect on innovation risk under fuzzy conditions.

Artificial intelligence in medicine
OBJECTIVES: We develop a fuzzy evaluation model that provides managers at different responsibility levels in pharmaceutical laboratories with a rich picture of their innovation risk as well as that of competitors. This would help them take better str...

Prediction of Drug Approval After Phase I Clinical Trials in Oncology: RESOLVED2.

JCO clinical cancer informatics
PURPOSE: Drug development in oncology currently is facing a conjunction of an increasing number of antineoplastic agents (ANAs) candidate for phase I clinical trials (P1CTs) and an important attrition rate for final approval. We aimed to develop a ma...

Prediction of clinical trial enrollment rates.

PloS one
Clinical trials represent a critical milestone of translational and clinical sciences. However, poor recruitment to clinical trials has been a long standing problem affecting institutions all over the world. One way to reduce the cost incurred by ins...

Harnessing explainable artificial intelligence for patient-to-clinical-trial matching: A proof-of-concept pilot study using phase I oncology trials.

PloS one
This study aims to develop explainable AI methods for matching patients with phase 1 oncology clinical trials using Natural Language Processing (NLP) techniques to address challenges in patient recruitment for improved efficiency in drug development....

Explainable machine learning prediction of edema adverse events in patients treated with tepotinib.

Clinical and translational science
Tepotinib is approved for the treatment of patients with non-small-cell lung cancer harboring MET exon 14 skipping alterations. While edema is the most prevalent adverse event (AE) and a known class effect of MET inhibitors including tepotinib, there...