ArticleElectrophoresis2025
A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development.
Article in Electrophoresis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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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.
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Who cites it
4 citing papers in PubMed.
- Quality by Design to Mitigate Aggregation: Mechanistic Insights and Analytical Strategies for Biopharmaceutical Manufacturing.Therapeutic innovation & regulatory science · 2026Review
- Development and Optimisation of a Stability-Indicating Analytical Method for Itraconazole in Drug Product by High-Performance Liquid Chromatography Using a QbD Approach.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Towards an Analytical Procedure Control Strategy for the Capillary Zone Electrophoresis Method for Monoclonal Antibodies: Alternatives for ε-Aminocaproic Acid and Triethylenetetramine.Electrophoresis · 2025Article
- A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development.Electrophoresis · 2025Article
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The ICH Q14 guideline introduces a structured framework for analytical method development based on Analytical Quality by Design (AQbD) principles, aiming to ensure robust, reliable, and fit-for-purpose methods throughout the product lifecycle. However, implementing ICH Q14 remains challenging due to the lack of complete examples and training resources, making it difficult for organizations to translate theory into practice. Although previous studies have applied AQbD to capillary electrophoresis method development, many have focused only on specific aspects such as the design of experiments (DoEs) or analytical target profile (ATP), leaving a gap in providing comprehensive, practical tools for the entire analytical lifecycle. This manuscript presents a novel, user-friendly approach to implementing ICH Q14 and AQbD, offering ready-to-implement tools and methodologies that simplify the process of method design, optimization, validation, and implementation. Through a stepwise process, the approach provides practical solutions for integrating AQbD principles into everyday workflows, bridging the gap between theoretical concepts and real-world applications. The approach has been thoroughly tested in diverse industrial settings, demonstrating its reliability and effectiveness. This work aims to facilitate the adoption of AQbD in analytical method development by providing structured tools, lessons learned, and best practices that align with ICH Q14 guidelines.
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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.