Articles with "clinical drug" as a keyword



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Use of Molecular Imaging in Clinical Drug Development: a Systematic Review

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Published in 2019 at "Nuclear Medicine and Molecular Imaging"

DOI: 10.1007/s13139-019-00593-y

Abstract: BackgroundMolecular imaging such as positron emission tomography (PET) and single-photon emission computed tomography (SPECT) can provide the crucial pharmacokinetic-pharmacodynamic information of a drug non-invasively at an early stage of clinical drug development. Nevertheless, not much… read more here.

Keywords: drug; drug development; molecular imaging; clinical drug ... See more keywords

Assessment of frequency and reporting of design changes among clinical drug trials published in influential medical journals.

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Published in 2019 at "European journal of internal medicine"

DOI: 10.1016/j.ejim.2019.08.009

Abstract: BACKGROUND Modifications of primary outcome measures after trial initiation can undermine their scientific validity. We aimed to quantify these changes and to characterize potential predictors in clinical drug trials published in high impact factor general… read more here.

Keywords: medicine; primary outcome; drug trials; clinical drug ... See more keywords
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Innovative highlights of clinical drug trial design

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Published in 2020 at "Translational Research"

DOI: 10.1016/j.trsl.2020.05.007

Abstract: Abstract Clinical trials serve as the gold standard to evaluate the efficacy and safety of tested drugs prior to marketing authorization. Nevertheless, there have been a few challenging issues well noted in traditional clinical trials… read more here.

Keywords: highlights clinical; trial; innovative highlights; drug ... See more keywords

Frailty in clinical drug trials: Frailty assessments, subgroup analyses and outcomes

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Published in 2024 at "British Journal of Clinical Pharmacology"

DOI: 10.1111/bcp.16034

Abstract: With population ageing, drug trials are increasingly turning their attention to including older, frailer people. This review aimed to provide an overview of how frailty was assessed in published studies related to clinical pharmacological trials,… read more here.

Keywords: treatment; drug trials; clinical drug; frailty clinical ... See more keywords

Incorporating transgender and nonbinary participants in phase 1 clinical drug trials: Current knowledge gaps and considerations

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Published in 2024 at "British Journal of Clinical Pharmacology"

DOI: 10.1111/bcp.16073

Abstract: Phase 1 clinical drug trials critically depend on the participation of healthy volunteers to evaluate the safety and pharmacokinetics of new medicinal products. Current selection criteria and health definitions often overlook the unique health profiles… read more here.

Keywords: transgender nonbinary; drug trials; clinical drug; current knowledge ... See more keywords

Leveraging patient‐centric sampling for clinical drug development and decentralized clinical trials: Promise to reality

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Published in 2022 at "Clinical and Translational Science"

DOI: 10.1111/cts.13411

Abstract: Advances in the technologies to enable patient‐centric sampling (PCS) have the potential to improve blood sample collection by enabling clinical trial participants to collect samples via self‐collection or with the help of a caregiver in… read more here.

Keywords: development; patient centric; clinical drug; centric sampling ... See more keywords

Navigating Drug–Drug Interactions in Clinical Drug Development: A Tutorial

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Published in 2025 at "Clinical and Translational Science"

DOI: 10.1111/cts.70342

Abstract: This tutorial provides essential guidelines and insights, in addition to regulatory guidance, for the evaluation of drug–drug interactions (DDIs), with a focus on the tools and timing of assessment critical for effective management of inclusion/exclusion… read more here.

Keywords: drug interactions; drug development; drug drug; clinical drug ... See more keywords
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Clinical Drug Trials

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Published in 2018 at "Pediatrics in Review"

DOI: 10.1542/pir.2016-0230

Abstract: 1. Amy Mason, MD, MSc* 1. *Bayer Pharmaceuticals, Whippany, NJ 1. Code of Federal Regulations Title 21, Part 312, Investigational New Drug Application. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=312. Accessed January 24, 2018 2. The… read more here.

Keywords: https www; drug trials; drug; clinical drug ... See more keywords

Kidney Cancer Models for Pre-Clinical Drug Discovery: Challenges and Opportunities

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Published in 2022 at "Frontiers in Oncology"

DOI: 10.3389/fonc.2022.889686

Abstract: Renal cell carcinoma (RCC) is among the most lethal urological malignancies once metastatic. The introduction of immune checkpoint inhibitors has revolutionized the therapeutic landscape of metastatic RCC, nevertheless, a significant proportion of patients will experience… read more here.

Keywords: drug discovery; rcc; clinical drug; pre clinical ... See more keywords

Challenges for Clinical Drug Development in Pulmonary Fibrosis

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Published in 2022 at "Frontiers in Pharmacology"

DOI: 10.3389/fphar.2022.823085

Abstract: Pulmonary fibrosis is a pathologic process associated with scarring of the lung interstitium. Interstitial lung diseases (ILDs) encompass a large and heterogenous group of disorders, a number of which are characterized by progressive pulmonary fibrosis… read more here.

Keywords: challenges clinical; development; pulmonary fibrosis; clinical drug ... See more keywords

Prospective Prediction of Dapaconazole Clinical Drug–Drug Interactions Using an In Vitro to In Vivo Extrapolation Equation and PBPK Modeling

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Published in 2022 at "Pharmaceuticals"

DOI: 10.3390/ph16010028

Abstract: This study predicted dapaconazole clinical drug–drug interactions (DDIs) over the main Cytochrome P450 (CYP) isoenzymes using static (in vitro to in vivo extrapolation equation, IVIVE) and dynamic (PBPK model) approaches. The in vitro inhibition of… read more here.

Keywords: vitro vivo; drug interactions; drug drug; clinical drug ... See more keywords