The DOI matches its Crossref record; 26 of the 26 references it cites were found in a registry or an index.
Q2(R1) Validation of Analytical Procedures: Text and Methodology
Abstract
International Conference on Harmonisation (ICH) Q2(R1) provides a formal overview of the criteria required to fully validate an analytical procedure. It highlights that the purpose of any method validation is to demonstrate that it is “suitable for its intended purpose”. This is a theme of this chapter, as too often there is a slavish desire to follow the guideline without truly understanding the strengths and weaknesses of the method that has been developed. The chapter discusses some of the benefits of developing methods using quality by design (QbD) approaches. The chapter also explores a framework for applying QbD to analytical methods. It further explores examples of validation of the analytical methods, for example, near-infrared spectroscopy (NIR), and demonstrates that this guidance is equally applicable to non-chromatographic methodologies. Finally, it is important to recognize that medicinal products are developed transnationally, with products being moved across global manufacturing networks.
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Thompson, M., Ellison, S. L. R., & Wood, R. (2002) · Pure and Applied Chemistry · doi:10.1351/pac200274050835 · Cited by 2,478
Development of validated stability-indicating assay methods—critical review
Bakshi, M., & Singh, S. (2002) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/s0731-7085(02)00047-x · Cited by 803
Multivariate data analysis in pharmaceutics: A tutorial review
Rajalahti, T., & Kvalheim, O. M. (2011) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2011.02.019 · Cited by 768
Guidance for robustness/ruggedness tests in method validation
Vander Heyden, Y., Nijhuis, A., Smeyers-Verbeke, J., Vandeginste, B. G. M., & Massart, D. L. (2001) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/s0731-7085(00)00529-x · Cited by 639
Guidelines from the International Conference on Harmonisation (ICH)
Branch, S. K. (2005) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2005.02.037 · Cited by 333
Modern HPLC for Practicing Scientists
Dong, M. W. (2006) · Wiley eBooks · doi:10.1002/0471973106 · Cited by 301
Method Validation in Pharmaceutical Analysis: A Guide to Best Practice
(2005) · Wiley eBooks · doi:10.1002/3527604685 · Cited by 271
Orthogonal Projection Approach Applied to Peak Purity Assessment
Sánchez, F. C., Toft, J., van den Bogaert, B., & Massart, D. L. (1996) · Analytical Chemistry · doi:10.1021/ac950496g · Cited by 267
Analysis of recent pharmaceutical regulatory documents on analytical method validation
Rozet, E., Ceccato, A., Hubert, C., Ziemons, E., Oprean, R., Rudaz, S., Boulanger, B., & Hubert, P. (2007) · Journal of Chromatography A · doi:10.1016/j.chroma.2007.03.111 · Cited by 266
Ruggedness and robustness testing
Dejaegher, B., & Heyden, Y. V. (2007) · Journal of Chromatography A · doi:10.1016/j.chroma.2007.02.086 · Cited by 221
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Zheng, W., Jiang, L., Lei, Q., Yang, J., Gao, X., Wang, W., Zhang, Y., Kong, T., Chen, Q., & Li, G. (2019) · Biological Procedures Online · doi:10.1186/s12575-019-0105-1 · Cited by 25
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Metadata
- Authors
- Borman, P., & Elder, D.
- Venue
- ICH Quality Guidelines
- Publisher
- Wiley
- Published
- 2017-09-27
- Pages
- 127-166
- OpenAlex
- W2762371850
- Cited by
- 746
- References
- 26
- Type
- other
- Language
- en
- Open access
- closed
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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