Results 1 to 10 of about 1,152,398 (267)

Patient-proxy agreement on change in acute stroke patient-reported outcome measures: a prospective study

open access: yesJournal of Patient-Reported Outcomes, 2021
Objectives Research has indicated proxies overestimate symptoms on patients’ behalves, however it is unclear whether patients and proxies agree on meaningful change across domains over time.
Brittany R. Lapin   +3 more
doaj   +1 more source

Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview

open access: yesCPT: Pharmacometrics & Systems Pharmacology, 2023
On September 30 and October 1, 2021, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics cosponsored a live virtual workshop titled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence ...
Andrew Babiskin   +12 more
doaj   +1 more source

Quantitative methods and modeling to assess COVID‐19‐interrupted in vivo pharmacokinetic bioequivalence studies with two reference batches

open access: yesCPT: Pharmacometrics & Systems Pharmacology, 2022
The coronavirus disease 2019 (COVID‐19) has presented unprecedented challenges to the generic drug development, including interruptions in bioequivalence (BE) studies.
Yuqing Gong   +12 more
doaj   +1 more source

Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

open access: yesCPT: Pharmacometrics & Systems Pharmacology, 2021
Establishing bioequivalence (BE) for dermatological drug products by conducting comparative clinical end point studies can be costly and the studies may not be sufficiently sensitive to detect certain formulation differences.
Eleftheria Tsakalozou   +2 more
doaj   +1 more source

Evaluation of model‐based bioequivalence approach for single sample pharmacokinetic studies

open access: yesCPT: Pharmacometrics & Systems Pharmacology, 2023
In a traditional pharmacokinetic (PK) bioequivalence (BE) study, a two‐way crossover study is conducted, PK parameters (namely the area under the time‐concentration curve [AUC] and the maximal concentration [Cmax]) are obtained by noncompartmental ...
Coralie Tardivon   +10 more
doaj   +1 more source

Deletion statistic accuracy in confirmatory factor models

open access: yesMethodological Innovations, 2020
Social science researchers now routinely use confirmatory factor models in scale development and validation studies. Methodologists have known for some time that the results of fitting a confirmatory factor model can be unduly influenced by one or a few ...
Jennifer Koran, Fathima Jaffari
doaj   +1 more source

Weighted single-step genomic best linear unbiased prediction integrating variants selected from sequencing data by association and bioinformatics analyses

open access: yesGenetics Selection Evolution, 2020
Background Sequencing data enable the detection of causal loci or single nucleotide polymorphisms (SNPs) highly linked to causal loci to improve genomic prediction.
Aoxing Liu   +10 more
doaj   +1 more source

Evaluation of Multi-Source High-Resolution Remote Sensing Image Fusion in Aquaculture Areas

open access: yesApplied Sciences, 2022
Image fusion of satellite sensors can generate a high-resolution multi-spectral image from inputs of a high spatial resolution panchromatic image and a low spatial resolution multi-spectral image for feature extraction and target recognition, such as ...
Weifeng Zhou   +4 more
doaj   +1 more source

In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products

open access: yesCPT: Pharmacometrics & Systems Pharmacology, 2019
The development of generic, single‐entity, drug–device combination products for orally inhaled drug products is challenging in part because of the complex nature of device design characteristics and the difficulties associated with establishing ...
Ross L. Walenga   +2 more
doaj   +1 more source

Quantitative Evaluation of Submerged Cavitation Jet Performance Based on Image Processing Method

open access: yesJournal of Marine Science and Engineering, 2022
The submerged cavitation jet is suitable for ocean engineering activities such as ship fouling cleaning, organic wastewater treatment, offshore oil drilling, and natural gas hydrate extraction due to its superior hydraulic performance and erosion ...
Xiao Zhong   +4 more
doaj   +1 more source

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