Results 201 to 210 of about 158,299 (299)

Model‐Informed Evaluation of Hydroxyurea Exposure During Lactation

Clinical Pharmacology &Therapeutics, EarlyView.
Hydroxyurea is a cornerstone therapy for sickle cell anemia; however, evidence guiding its use during lactation remains limited. This study aimed to develop a population pharmacokinetic (PK) model to characterize hydroxyurea disposition in maternal plasma and breast milk, and to quantify infant exposure under clinically relevant breastfeeding scenarios.
Anhar Hosawi, Kei Irie, Min Dong, Julie Ware, Russell Ware, Tomoyuki Mizuno   +5 more
wiley   +1 more source

Use of real-world evidence in the U.S. Food and Drug Administration and the European Medicines Agency approvals of oncology products supported by single-arm trials (2022-2025). [PDF]

Oncologist
Su L, Chen L, Mamtani R, Betigeri S, Hubbard R, Burcu M.   +5 more
europepmc   +1 more source

Regulatory Research Priorities for AI Use in the Medicine Lifecycle: A European Perspective with Global Relevance

Clinical Pharmacology &Therapeutics, EarlyView.
Regulatory bodies play a central role in providing guidance that enables safe and effective use of artificial intelligence tools in medicine development and evaluation. Regulators can also act as catalysts for regulatory science research. To inform these efforts, a European‐wide survey was conducted to solicit stakeholder perspectives on the priority ...
Luis C. Pinheiro, Amanda C. Langston, Marie Orre, Joerg Zinserling, Konstantina Boumaki, Bastian V. H. Hornung, Siobhan O'Sullivan, Gabriel Westman, Karl Broich, Peter Arlett   +9 more
wiley   +1 more source

State of the industry: integration of 3Rs principles and new approach methodologies in non-clinical product development through fit-for-purpose. [PDF]

Front Med (Lausanne)
Poppenborg SM, Webster DA, Carlsson B.
europepmc   +1 more source

Noh performance of Ema, 1975, EMA06

core  

Risk of Bias Associated with Varying Sampling Strategies for External Comparator Cohorts for Single‐Arm Trials: Insights from Aggressive Lymphoma

Clinical Pharmacology &Therapeutics, EarlyView.
Marketing authorizations for oncology drugs are often based on single‐arm trials (SATs), and real‐world data‐based external comparator cohorts (ECCs) are increasingly explored to contextualize results. In retrospective studies, comparators may be identified by time of diagnosis but included based on time of relapse; such sampling strategies can ...
Mikkel Runason Simonsen, Shiva Leisner, Ahmed Ludvigsen Al‐Mashhadi, Laurids Østergaard Poulsen, Matthew Maurer, Lasse Hjort Jakobsen, Tarec Christoffer El‐Galaly   +6 more
wiley   +1 more source

A Smartphone-Based Ecological Momentary Intervention for Workplace Mental Health: Randomized Controlled Trial. [PDF]

JMIR Mhealth Uhealth
Li S, Lo LHL, Lau CYC, Lam M, Chan M.
europepmc   +1 more source

Model‐Informed Approaches for Pediatric Type 2 Diabetes Evidence Generation: Insights from a Model‐Based Longitudinal HbA1c Meta‐Analysis from EMA Marketing Authorization Applications

Clinical Pharmacology &Therapeutics, EarlyView.
Evidence generation for antihyperglycemic therapies in pediatric type 2 diabetes mellitus (T2DM) remains challenging, with most randomized trials failing to demonstrate statistically significant reductions in glycated hemoglobin (HbA1c), partly due to substantial between‐subject variability.
Pieter J. Colin, Efthymios Manolis, Jeroen V. Koomen   +2 more
wiley   +1 more source

Smartphone-Based Ecological Momentary Assessment Among Community-Dwelling Older Adults: Observational Feasibility and Acceptability Study. [PDF]

JMIR Form Res
Liang X, Park SH.
europepmc   +1 more source

Toward Fit‐for‐Purpose Data for Drug Assessment in Non‐small Cell Lung Cancer: A Core Dataset

Clinical Pharmacology &Therapeutics, EarlyView.
Considering the high unmet medical need in people with non‐small cell lung cancer (NSCLC), the drug assessment for targeted therapies often rely on small populations and single‐arm trials, challenging the evaluation by regulatory authorities, health technology assessment bodies (HTAb), and clinicians.
Geeske F. Grit, Maaike van Dartel, Laura Rodwell, Hanneke van der Woude, Cornelis Boersma, Peter G. M. Mol, Doranne Hilarius   +6 more
wiley   +1 more source