ArticleJournal of pharmaceutical sciences2020
An NMR-Based Similarity Metric for Higher Order Structure Quality Assessment Among U.S. Marketed Insulin Therapeutics.
Article in Journal of pharmaceutical sciences, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 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
16 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
- 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
- Recommendation for Clarifying FDA Policy in Evaluating "Sameness" of Higher Order Structure for Generic Peptide Therapeutics.The AAPS journal · 2024Article
- Characterization of Higher Order Structural Changes of a Thermally Stressed Monoclonal Antibody via Mass Spectrometry Footprinting and Other Biophysical Approaches.Analytical chemistry · 2023Article
- Application of NMR and Chemometric Analyses to Better Understand the Quality Attributes in pH and Thermally Degraded Monoclonal Antibodies.Pharmaceutical research · 2023Article
- Direct Assessment of Oligomerization of Chemically Modified Peptides and Proteins in Formulations using DLS and DOSY-NMR.Pharmaceutical research · 2023Article
- Assessing the Structural and Functional Similarity of Insulin Glargine Biosimilars.Journal of diabetes science and technology · 2023Article
- Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs.The AAPS journal · 2023Article
- Structural Fingerprinting of siRNA Therapeutics by Solution NMR Spectroscopy.Nucleic acid therapeutics · 2022Article
- Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms.Frontiers in bioengineering and biotechnology · 2022Review
- Principal Component Analysis of 1D 1H Diffusion Edited NMR Spectra of Protein Therapeutics.Journal of pharmaceutical sciences · 2021Article
- NMR Spectroscopy for Protein Higher Order Structure Similarity Assessment in Formulated Drug Products.Molecules (Basel, Switzerland) · 2021Article
- 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
- 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
7 authors.
Funding
Abstract
Protein or peptide higher order structure (HOS) is a quality attribute that could affect therapeutic efficacy and safety. Where appropriate, the HOS similarity between a proposed follow-on product and the reference listed drug should be demonstrated during regulatory assessment. Establishing quantitative HOS similarity for 2 drug substances, manufactured by different processes, has been challenging. Herein, HOS differences among U.S. marketed insulin drug products (DPs) were quantified using nuclear magnetic resonance spectra and principal component analysis (PCA). Then, the unitless 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.