| Autor: |
Mohammad Yahyah, John J. Peterson |
| Rok vydání: |
2009 |
| Předmět: |
|
| Zdroj: |
Statistics in Biopharmaceutical Research. 1:441-449 |
| ISSN: |
1946-6315 |
| Popis: |
The ICH Q2 (R1) Guidance on Validation of Analytical Procedures states that a robustness assessment for an analytical method should provide “an indication of its reliability during normal usage.” The concept of “design space” as specified in the ICH Q8 Guidance may be used to create a zone of reliable robustness for an analytical method or pharmaceutical process. A Bayesian approach to design space as outlined by Peterson (2004) accounts for model parameter uncertainty, correlation among the quality responses at each fixed operating condition, and method response multiplicity. Two examples are provided to illustrate the application of a Bayesian design space to assessing reliability/robustness. One example is about assessing the ability of an HPLC analytical method to meet system suitability criteria and the other deals with a crystallization process for an active pharmaceutical ingredient. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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