Results 1 to 10 of about 31,502 (199)

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

Journal 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, Nicolas R. Thompson, Andrew Schuster, Irene L. Katzan   +3 more
doaj   +1 more source

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

CPT: 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, Fang Wu, Youssef Mousa, Ming‐Liang Tan, Eleftheria Tsakalozou, Ross L. Walenga, Miyoung Yoon, Sam G. Raney, James E. Polli, Anna Schwendeman, Vishalakshi Krishnan, Lanyan Fang, Liang Zhao   +12 more
doaj   +1 more source

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

CPT: 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, Kairui Feng, Peijue Zhang, Jieon Lee, Yuzhuo Pan, Zhen Zhang, Zhanglin Ni, Tao Bai, Miyoung Yoon, Bing Li, Carol Y. Kim, Lanyan Fang, Liang Zhao   +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%

CPT: 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, Andrew Babiskin, Liang Zhao   +2 more
doaj   +1 more source

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

CPT: 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, Florence Loingeville, Mark Donnelly, Kairui Feng, Wanjie Sun, Guoying Sun, Stella Grosser, Liang Zhao, Lanyan Fang, France Mentré, Julie Bertrand   +10 more
doaj   +1 more source

Evaluating Mandibular Cortical Index Quantitatively [PDF]

European Journal of Dentistry, 2008
ABSTRACTObjectives: The aim was to assess whether Fractal Dimension and Lacunarity analysis can discriminate patients having different mandibular cortical shape.Methods: Panoramic radiographs of 52 patients were evaluated for mandibular cortical index. Weighted Kappa between the observations were varying between 0.718-0.805.
Fusun, Yasar, Faruk, Akgunlu
openaire   +2 more sources

Deletion statistic accuracy in confirmatory factor models

Methodological 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

Genetics 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, Mogens Sandø Lund, Didier Boichard, Emre Karaman, Bernt Guldbrandtsen, Sebastien Fritz, Gert Pedersen Aamand, Ulrik Sander Nielsen, Goutam Sahana, Yachun Wang, Guosheng Su   +10 more
doaj   +1 more source

Quantitative evaluation of neuropharmacological trials [PDF]

Clinical Pharmacology & Therapeutics, 1974
The clinician's ability to classify a patient's neurophysiological deficits into such categories as mild, moderate, and severe does not readily allow the detection of small but significant changes in function over time. Clinical neurologists, for example, are discovering that the standard neurological examination is not sufficient to critically ...
Potvin, A. R., Albers, J. W., Repa, B. S., Henderson, W. G., Walker, J. E., Stribley, R. F., Pew, R. W., Tourtellotte, W. W.   +7 more
openaire   +3 more sources

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

CPT: 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, Andrew H. Babiskin, Liang Zhao   +2 more
doaj   +1 more source