Based upon the results of a bioequivalence study in 18 male and female healthy volunteers receiving each ibuprofen 400 mg at a time interval of 3 days the issue of the intrasubject variation is discussed. It was shown that there was bioequivalence as to the parameters Cmax, AUC0-tlast und AUC0-infinity in the volunteers who repeatedly received the same preparation. The same is true for the secondary target parameters tmax und t1/2. In the present study the intrasubject variability was determined to be 10%. Since ibuprofen does not belong to the drugs with problematic bioavailability it can be expected that in case of repeated application at an interval limited in time equal results are achieved with considerable intra-and intersubject variations.
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Purpose: The purpose of this study is to describe the inter- and intra-individual differences in the platelet concentration between blood and platelet-rich plasma (PRP) preparation, assess intersubject differences considering demographic and anthropometric variables, describe PRP code distribution and analyse intrasubject variability.
Methods: A retrospective analysis was conducted using a single-centre patient database from November 2021 to November 2023. It included patients with musculoskeletal pathologies treated with PRP injections.
Psychophysiology
January 2025
Department of Psychology, Ben-Gurion University of the Negev, Beer Sheva, Israel.
Cognitive control deficits and increased intra-subject variability have been well established as core characteristics of attention deficit hyperactivity disorder (ADHD), and there is a growing interest in their expression at the neural level. We aimed to study neural variability in ADHD, as reflected in theta inter-trial phase coherence (ITC) during error processing, a process that involves cognitive control. We examined both traditional event-related potential (ERP) measures of error processing (i.
View Article and Find Full Text PDFJ Biomed Opt
January 2025
University of Toronto, University Health Network, Princess Margaret Cancer Centre, Department of Medical Biophysics, Toronto, Ontario, Canada.
Significance: Personalized photodynamic therapy (PDT) treatment planning requires knowledge of the spatial and temporal co-localization of photons, photosensitizers (PSs), and oxygen. The inter- and intra-subject variability in the photosensitizer concentration can lead to suboptimal outcomes using standard treatment plans.
Aim: We aim to quantify the PS spatial variation in tumors and its effect on PDT treatment planning solutions.
Pharmaceutics
December 2024
Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, 1649-003 Lisbon, Portugal.
When companies are uncertain about the potential of a new formulation to be bioequivalent to a Reference product, it is common practice to carry out downsized pilot studies as a gatekeeping in vivo strategy to decide whether to move forward or not with a full-size pivotal study. However, due to the small study size, these studies are inarguably more sensitive to variability. To address and mitigate the uncertainty of the conclusions of pilot studies concerning the maximum observed concentration (C), the factor was proposed as an alternative approach to the average bioequivalence statistical methodology.
View Article and Find Full Text PDFClin Transl Sci
December 2024
Clinical Pharmacology, AbbVie Inc., North Chicago, Illinois, USA.
Recent reports suggest that plasma riboflavin may serve as a biomarker for BCRP inhibition in humans. However, the clinical data supporting this claim have been limited, with only two studies showing modest increases in riboflavin levels after administration of a BCRP inhibitor. We have recently demonstrated that co-administration of 375 mg once daily (q.
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