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Published on: December 1, 2020
Validation in context of bioanalytical research papers.
Eduard Rogatsky1, Vlad Tomuta, Daniel T Stein
1Core Analytical Laboratory, General Clinical Research Center, Albert Einstein College of Medicine of Yeshiva University, Bronx, NY 10461, USA. rogatsky@aecom.yu.edu
Chromatography journals increasingly publish analytical assay validation studies, neglecting method development. This trend overlooks the crucial intellectual aspects of creating robust chromatographic methods.
Area of Science:
- Analytical Chemistry
- Chromatography
- Method Development
Background:
- A rise in application papers focusing on analytical assay validation is observed in leading chromatography journals.
- These papers often provide extensive validation details but limited information on method development and optimization.
Purpose of the Study:
- To analyze the implications of the trend towards prioritizing assay validation over method development in chromatography.
- To advocate for a renewed focus on the intellectual contributions inherent in chromatographic method development.
Main Methods:
- Literature analysis of publications in top-ranked chromatographic journals.
- Discussion of the impact of current publication trends on the field.
Main Results:
- The current publication landscape in chromatography journals disproportionately features analytical assay validation.
- There is a noticeable lack of detailed reporting on the method development and optimization phases.
Conclusions:
- The emphasis on validation over development may hinder scientific progress and innovation in chromatography.
- Re-emphasizing the intellectual rigor of method development is crucial for advancing the field.
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