ArticleAAPS PharmSciTech2018
Chemometric Methods to Quantify 1D and 2D NMR Spectral Differences Among Similar Protein Therapeutics.
Article in AAPS PharmSciTech, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed.
- An Orthogonal Framework for Higher-Order Structural and In Vitro Functional Comparability of Chemically Synthesized Liraglutide Relative to an rDNA-Origin Reference Product.Pharmaceutical research · 2026Article
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- An Automated Tool for Glycosimilarity Assessment of mAb Therapeutic Biosimilars: Trastuzumab and Bevacizumab as Case Studies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Article
- Impact of structure and formulation changes on the function of insulin products.Frontiers in endocrinology · 2025Review
- Structural Relationships to Efficacy for Prazole-Derived Antivirals.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Article
- First Generic Teriparatide: Structural and Biological Sameness to Its Reference Medicinal Product.Pharmaceutics · 2024Article
- Application of NMR and Chemometric Analyses to Better Understand the Quality Attributes in pH and Thermally Degraded Monoclonal Antibodies.Pharmaceutical research · 2023Article
- Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs.The AAPS journal · 2023Article
- Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms.Frontiers in bioengineering and biotechnology · 2022Review
- NMR Spectroscopy for Protein Higher Order Structure Similarity Assessment in Formulated Drug Products.Molecules (Basel, Switzerland) · 2021Article
- Principal component analysis for automated classification of 2D spectra and interferograms of protein therapeutics: influence of noise, reconstruction details, and data preparation.Journal of biomolecular NMR · 2020Article
- Assessment of the Higher-Order Structure of Formulated Monoclonal Antibody Therapeutics by 2D Methyl Correlated NMR and Principal Component Analysis.Current protocols in protein science · 2020Article
- Comparative Analysis of One-Dimensional Protein Fingerprint by Line Shape Enhancement and Two-DimensionalAnalytical chemistry · 2020Article
- An NMR-Based Similarity Metric for Higher Order Structure Quality Assessment Among U.S. Marketed Insulin Therapeutics.Journal of pharmaceutical sciences · 2020Article
- The metaRbolomics Toolbox in Bioconductor and beyond.Metabolites · 2019Review
- Selective suppression of excipient signals in 2DJournal of biomolecular NMR · 2018Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
NMR spectroscopy is an emerging analytical tool for measuring complex drug product qualities, e.g., protein higher order structure (HOS) or heparin chemical composition. Most drug NMR spectra have been visually analyzed; however, NMR spectra are inherently quantitative and multivariate and thus suitable for chemometric analysis. Therefore, quantitative measurements derived from chemometric comparisons between spectra could be a key step in establishing acceptance criteria for a new generic drug or a new batch after manufacture change. To measure the capability of chemometric methods to differentiate comparator NMR spectra, we calculated inter-spectra difference metrics on 1D/2D spectra of two insulin drugs, Humulin R® and Novolin R®, from different manufacturers. Both insulin drugs have an identical drug substance but differ in formulation. Chemometric methods (i.e., principal component analysis (PCA), 3-way Tucker3 or graph invariant (GI)) were performed to calculate Mahalanobis distance (D
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.