Robert Nelson
Overview
Explore the profile of Robert Nelson including associated specialties, affiliations and a list of published articles.
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80
Citations
969
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Recent Articles
1.
Timmerman P, White S, Adcock N, Arfvidsson C, Barfield M, Cowan K, et al.
Bioanalysis
. 2025 Feb;
:1-4.
PMID: 39985138
The release of the ICH M12 Guideline on Drug Interaction Studies has reignited discussions around assay validation requirements for assays such as plasma protein-binding studies. Even though the ICH M12...
2.
Bierer B, Koppelman E, Croker A, Hosseinzadeh S, Hovinga C, Joffe S, et al.
Front Pediatr
. 2024 Nov;
12:1481754.
PMID: 39600960
The importance of patient engagement in product development and clinical research is widely acknowledged. In pediatrics, parents and guardians are often vocal advocates for their children in the process, but...
3.
Hagman C, Chasseigne G, Nelson R, Anlauff F, Kagan M, Goldfine A, et al.
Front Immunol
. 2024 Nov;
15:1438251.
PMID: 39588370
The clinical immunogenicity assessment for complex multidomain biological drugs is challenging due to multiple factors that must be taken into consideration. Here, we describe a strategy to overcome multiple bioanalytical...
4.
Vuocolo B, Sierra R, Brooks D, Holder C, Urbanski L, Rodriguez K, et al.
J Neurodev Disord
. 2024 Sep;
16(1):52.
PMID: 39251895
Background: The utilization of genomic information to improve health outcomes is progressively becoming more common in clinical practice. Nonetheless, disparities persist in accessing genetic services among ethnic minorities, individuals with...
5.
Goodman J, Cowan K, Golob M, Nelson R, Baltrukonis D, Bloem K, et al.
Bioanalysis
. 2024 Aug;
16(17-18):905-913.
PMID: 39119660
Immunogenicity regulatory guidance and industry recommendations have evolved over the last two decades since unexpected immune reactions were first reported with erythropoietin. Since then, the guidelines and practices for immunogenicity...
6.
Cowan K, Kunz U, Blattmann P, Gulati P, Hughes R, Andersen L, et al.
Bioanalysis
. 2024 Aug;
16(16):835-842.
PMID: 39101487
The European Bioanalysis Forum, alongside key industry stakeholders, has been driving the discussions around the implementation of context-of use for biomarker assays to ensure that these assays are validated appropriately...
7.
Rivera-Paredez B, Argoty-Pantoja A, Velazquez-Cruz R, Salmeron J, Jimenez-Corona A, Gonzalez-Villalpando C, et al.
Nutr Res
. 2024 Jun;
127:53-62.
PMID: 38876039
We hypothesized that higher scores on the dietary inflammatory index (DII) would be associated with a lower glomerular filtration rate (GFR). This cross-sectional study included 2098 participants from Mexican Teachers...
8.
Li Y, Nelson R, Izem R, Broglio K, Mundayat R, Gamalo M, et al.
Ther Innov Regul Sci
. 2024 Apr;
58(4):634-644.
PMID: 38653950
The use of master protocols allows for innovative approaches to clinical trial designs, potentially enabling new approaches to operations and analytics and creating value for patients and drug developers. Pediatric...
9.
Rivera-Paredez B, Morales M, Velazquez-Cruz R, Salmeron J, Jimenez-Corona A, Balderas-Arteaga N, et al.
Clin Nutr
. 2024 Mar;
43(4):1062-1069.
PMID: 38547595
Background & Aims: To evaluate the association between soft drinks (SDs) consumption and estimated glomerular filtration rate (eGFR) in a Mexican adult population. Methods: We used data from the RenMex...
10.
Timmerman P, Barfield M, Portabella E, Calogero S, Cowan K, Faber J, et al.
Bioanalysis
. 2024 Feb;
16(5):259-270.
PMID: 38315622
The ICH M10 guideline on bioanalytical method validation and sample analysis is being adopted since 2023. However, and inevitably, some paragraphs or requirements remain ambiguous and are open for different...