Results 161 to 170 of about 326,926 (265)

Comorbidities Associated With Chronic Hepatitis C Among Medicaid Beneficiaries, 2016-2020. [PDF]

open access: yesAm J Prev Med
Estadt AT   +4 more
europepmc   +1 more source

A Practical Guide to Implementing Real‐World Evidence as Primary Basis for Approval and Label Expansion

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
In June 2026, the FDA issued a revised draft guidance describing the circumstances in which one adequate and well‐controlled clinical investigation plus confirmatory evidence may satisfy the statutory substantial evidence standard for establishing efficacy and safety. Confirmatory evidence includes real‐world evidence (RWE).
Tracy J. Mayne   +2 more
wiley   +1 more source

AASLD practice guidance on drug, herbal, and dietary supplement–induced liver injury

open access: yes, 2022
Hepatology, EarlyView.
Robert J. Fontana   +6 more
wiley   +1 more source

In Silico Clinical Trials in Drug Development: Virtual Patients, Applications, and Regulatory Convergence

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Conventional clinical trials remain the benchmark for evaluating therapeutic safety and efficacy, yet they are constrained by escalating costs, withdrawal over the extended follow‐up periods, recruitment difficulties, ethical limits, and a restricted ability to characterize heterogeneous populations.
Maximilian Balmus   +7 more
wiley   +1 more source

A practical difference from the normal approach to evaluate natural killer (NK) cells and NK cell neoplasms by flow cytometry

open access: yesCytometry Part B: Clinical Cytometry, EarlyView.
Abstract Natural killer (NK) cell neoplasms span indolent to highly aggressive entities, and flow cytometric immunophenotyping is central to their detection and classification. However, distinguishing reactive from neoplastic NK cell expansions can be challenging because NK cells lack somatically recombined antigen receptors, and reactive states may ...
Aaron J. Wilk   +7 more
wiley   +1 more source

Subset‐specific and tissue‐specific expression of NK‐cell markers and killer immunoglobulin‐like receptors: Implications for NK‐cell clonality assessment

open access: yesCytometry Part B: Clinical Cytometry, EarlyView.
Abstract Accurate immunophenotypic evaluation of natural killer (NK)‐cell neoplasms is challenging because NK‐cells lack somatically rearranged antigen receptors, are comprised of phenotypically distinct subsets, and exhibit tissue‐specific subset distribution. We developed a flow cytometry (FC) panel for NK‐cell immunophenotypic analysis and clonality
Valerie Woodings   +7 more
wiley   +1 more source

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