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Dataset results
19 results for “Pharmacodynamic biomarkers”
Data from: Validation of serum neurofilaments as prognostic & potential pharmacodynamic biomarkers for ALS
<p><span><span><span><span><span><span><span><span><span><span><span><u>Objective</u>. Identify preferred neurofilament assays, and clinically validate serum NfL and pNfH as prognostic and potential pharmacodynamic biomarkers relevant to ALS therapy development. </span></span></span></span></span></span></span></span></span></span></span></p> <p><span><span><span><span><span><span><span><span><span><span><span><u>Methods</u>. Prospective, multi-center, longitudinal observational study of patients with ALS (n=229), primary lateral sclerosis (PLS, n=20) and progressive muscular atrophy (PMA, n=11). Biological specimens were collected, processed and stored according to strict standard operating procedures (SOPs) <sup>1</sup>. Neurofilament assays were performed in a blinded manner by independent contract research organizations (CROs). </span></span></span></span></span></span></span></span></span></span></span></p> <p><span><span><span><span><span><span><span><span><span><span><span><u>Results</u>. For serum NfL and pNfH measured using the Simoa assay, there were no missing data (i.e. both technical replicates below the lower limit of detection were not encountered). For the Iron Horse and Euroimmun pNfH assays, such missingness was encountered in ~4% and ~10% of serum samples respectively. Mean coefficients of variation (CVs) for pNfH in serum and CSF were ~4-5% and ~2-3% respectively in all assays. Baseline NfL concentration, but not pNfH, predicted the future ALSFRS-R slope and survival. Incorporation of baseline serum NfL into mixed effects models of ALSFRS-R slopes yields an estimated sample size saving of ~8%. Depending on the method used to estimate effect size, use of serum NfL (and perhaps pNfH) as pharmacodynamic biomarkers, instead of the ALSFRS-R slope, yields significantly larger sample size savings.</span></span></span></span></span></span></span></span></span></span></span></p> <p><u>Conclusions</u><span><span><span><span><span><span><span><span><span><span><span>. Serum NfL may be considered a clinically validated prognostic biomarker for ALS. Serum NfL (and perhaps pNfH), quantified using the Simoa assay, have potential utility as pharmacodynamic biomarkers of treatment effect. </span></span></span></span></span></span></span></span></span></span></span></p>
Data from: Validation of serum neurofilaments as prognostic & potential pharmacodynamic biomarkers for ALS
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Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Direct Oral Anticoagulants
ClinicalTrials.gov study NCT03161496. IPD Sharing: Not stated. Countries: 1. Publications: 3.
Pharmacodynamic Biomarkers of Standard Anti-microtubule Drugs as Assessed by Early Tumor Biopsy
ClinicalTrials.gov study NCT03393741. IPD Sharing: NO. Countries: 1. Publications: 1.
Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Ticagrelor
ClinicalTrials.gov study NCT03161002. IPD Sharing: Not stated. Countries: 1. Publications: 2.
A Phase I, Randomized, Placebo-controlled, Double Blind, Repeat Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Gastrointestinal Transit Time and Pharmacodynamic Biomarke
ClinicalTrials.gov study NCT02798991. IPD Sharing: Not stated. Countries: 1. Publications: 1.
A Study to Examine the Pharmacodynamic Effects of GSK1034702 on Neurophysiological Biomarkers of Cognition in Nicotine Abstained Otherwise Healthy Smokers
ClinicalTrials.gov study NCT01371799. IPD Sharing: YES. Countries: 1. Publications: 2.
Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products
ClinicalTrials.gov study NCT04183491. IPD Sharing: YES. Countries: 1. Publications: 0.
Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors
ClinicalTrials.gov study NCT04189484. IPD Sharing: YES. Countries: 1. Publications: 0.
Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)
ClinicalTrials.gov study NCT05136690. IPD Sharing: YES. Countries: 1. Publications: 0.
Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013)
ClinicalTrials.gov study NCT01888952. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists
ClinicalTrials.gov study NCT04183192. IPD Sharing: YES. Countries: 1. Publications: 0.
A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)
ClinicalTrials.gov study NCT04699604. IPD Sharing: NO. Countries: 1. Publications: 0.
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agg
ClinicalTrials.gov study NCT05318534. IPD Sharing: NO. Countries: 1. Publications: 0.
Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II
ClinicalTrials.gov study NCT05764356. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Pharmacodynamic Biomarkers and Differential Effects of TNF- and GM-CSF-Targeting Biologics in Rheumatoid Arthritis
GEO Series GSE120178. Homo sapiens. 147 samples. Type: Expression profiling by high throughput sequencing.
Pharmacodynamic Effects and Predictive Biomarkers With Ruxolitinib in Operable Head and Neck Cancer
ClinicalTrials.gov study NCT02593929. IPD Sharing: Not stated. Countries: 0. Publications: 0.
Evaluating MiRomics and Integrative Proteomics for Identification of Plasma miRNAs as Potential Pharmacodynamic Biomarkers of IFNβ-1a Biologics
GEO Series GSE308162. Homo sapiens. 372 samples. Type: Non-coding RNA profiling by high throughput sequencing.
Evaluating the utility of proteomics for the identification of circulating pharmacodynamic biomarkers of IFNβ-1 biologics
GEO Series GSE207945. Homo sapiens. 395 samples. Type: Protein profiling by protein array.
ScienceDex guides
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These curated guides explain access requirements, typical timelines, costs, and reuse considerations for widely used research datasets.
Allen Brain Atlas
Allen Brain Atlas is an Allen Institute collection of brain map atlases, datasets, APIs, and analysis tools covering mouse, human, and non-human primate brain resources.
Annotated Behaviour and Observability Dataset (ABODe)
ABODe is a University of Edinburgh DataShare dataset for behavior classification in group-housed mice using home-cage video, identities, bounding boxes, ground-plate positions, and annotator labels.
DANDI Archive for NWB datasets
DANDI is a BRAIN Initiative archive for publishing and sharing neurophysiology data, including electrophysiology, optophysiology, and behavioral data packaged as NWB and related standards.
International Brain Laboratory public data
The International Brain Laboratory public data releases expose standardized mouse decision-making experiments, including Neuropixels recordings, widefield calcium imaging, behavior, and session metadata accessed through the ONE API.
OpenNeuro
OpenNeuro is a free, open platform for sharing neuroimaging datasets, with public search, dataset pages, and download paths for web, S3, DataLad, and the OpenNeuro CLI.