ReviewJournal of peptide science : an official publication of the European Peptide Society2025
Regulatory Guidelines for the Analysis of Therapeutic Peptides and Proteins.
Review in Journal of peptide science : an official publication of the European Peptide Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 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
13 citing papers in PubMed.
- Artificial intelligence-assisted design of self-assembling peptide hydrogels for neural regeneration: Principles and opportunities.Bioactive materials · 2027Review
- Preclinical Efficacy and Safety Study of a Novel Dermal Fibroblast Modulating Drug, SLI-F06, in Cutaneous Wound Healing.MedComm · 2026Article
- Liposome-Based Photodynamic Therapy for Breast Cancer: Innovations in Targeted Delivery, Combination Strategies, and Clinical Translation.International journal of molecular sciences · 2026Review
- Microalgal therapeutic peptides: From biomass to bone tissue engineering.Materials today. Bio · 2026Review
- From spatial maps to treatment decisions: a roadmap for integrating explainable AI with multi-omics to guide precision immunotherapy.Biotechnology notes (Amsterdam, Netherlands) · 2026Review
- Next-Generation Anticancer Peptides: Engineering, Nanotheranostics and Clinical Translation.Nanotheranostics · 2026Review
- From bench to bedside: experimental pharmacology approaches to overcome bioavailability, stability, and translational barriers of bioactive peptides from natural sources.Frontiers in pharmacology · 2026Review
- Progress in peptide and protein therapeutics: Challenges and strategies.Acta pharmaceutica Sinica. B · 2025Review
- Formulation of Recombinant Therapeutic Proteins: Technological Innovation, Regulations, and Evolution Towards Buffer-Free Formulations.Pharmaceutics · 2025Review
- Recent advances in the therapeutics and modes of action of a range of agents used to treat ulcerative colitis and related inflammatory conditions.Inflammopharmacology · 2025Review
- Therapeutic Peptides: Recent Advances in Discovery, Synthesis, and Clinical Translation.International journal of molecular sciences · 2025Review
- Antimicrobial peptides: natural templates for next-generation therapeutics against antimicrobial resistance.Frontiers in cellular and infection microbiology · 2025Review
- Addressing challenging impurities in fusion proteins: A comprehensive review and cost-effective strategy for HCP and low molecular weight species control.Biotechnology progressReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
Peptides and proteins have become increasingly important in the treatment of various diseases, including infections, metabolic disorders, and cancers. Over the past decades, the number of approved peptide- and protein-based drugs has grown significantly, now accounting for about 25% of the global pharmaceutical market. This increase has been recorded since the introduction of the first therapeutic peptide, insulin, in 1921. Therapeutic peptides and proteins offer several advantages over small molecule drugs, including high specificity, potency, and safety; however, they also face challenges related to instability in liquid formulations. To address this issue, numerous formulation techniques have been developed to enhance their stability. In either state, physical and chemical characterization of the peptide or protein of interest is crucial for ensuring the identity, purity, and activity of these therapeutic agents. Regulatory bodies such as the FDA, ICH, and EMA have established guidelines for the analysis, stability testing, and quality control of peptides and biologics to ensure the safety and effectiveness of these drugs. In the present review, these guidelines and the consequences thereof are summarized and provided to support the notion of developing tailored bioanalytical workflows for each peptide or protein drug.
Indexed as
Identifiers
What Socratic holds
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 Socratic graph.