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

