Results 221 to 230 of about 15,497 (292)

Joint copula‐based beta regression with covariate‐dependent dispersion for malaria indicators

open access: yesCanadian Journal of Statistics, EarlyView.
Abstract Malaria surveillance relies on multiple indicators that reflect different aspects of transmission and disease burden, yet these outcomes are often analyzed separately under constant‐variance assumptions. Such approaches may obscure residual dependence and heterogeneity in variability. Using Demographic and Health Survey data from Burkina Faso (
Guanjie Lyu, Cindy Feng
wiley   +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

open access: yesClinical 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   +2 more
wiley   +1 more source

Model‐based clinical pharmacology profiling of subcutaneous nivolumab in renal cell carcinoma: Bridging to alternative dosing regimens and indications

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
A novel model‐informed drug development (MIDD) approach was employed to derive the coprimary endpoints (time‐averaged serum concentration over 28 days [Cavgd28] and minimum serum concentration at steady state [Cminss]) of the phase III CheckMate 67T study (NCT04810078).
Yue Zhao   +5 more
wiley   +1 more source

Financing a Private Practice: A Practical Framework for Plastic Surgeons. [PDF]

open access: yesPlast Reconstr Surg Glob Open
Mosca N   +6 more
europepmc   +1 more source

Considerations for the Integration of Clinical Trials and Real‐World Data

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
As clinical decision‐making increasingly moves toward individualized and context‐specific treatment recommendations, reliance on any single evidence source, randomized or observational, may be insufficient. Principled integration of randomized controlled trials and real‐world data, grounded in explicit causal frameworks, offers a path toward evidence ...
Sky Qiu   +19 more
wiley   +1 more source

Overview of Regulatory Guidelines Related to Methods and Models for Small Populations

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
This paper provides an overview of approaches and related guidelines from the EMA, FDA, and ICH that are relevant for obtaining clinical evidence for small populations to support regulatory decision making. The approaches are grouped into three categories: (1) maximizing the attainable sample size, (2) adapting the trial design to deal with a small ...
Laurens Sluijterman   +6 more
wiley   +1 more source

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