| Grant number: | 17/04539-2 |
| Support Opportunities: | Regular Research Grants |
| Start date: | September 01, 2017 |
| End date: | February 29, 2020 |
| Field of knowledge: | Health Sciences - Pharmacy - Medicines Analysis and Control |
| Principal Investigator: | Felipe Rebello Lourenço |
| Grantee: | Felipe Rebello Lourenço |
| Host Institution: | Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil |
| City of the host institution: | São Paulo |
Abstract
The analytical methods employed in quality control of drugs and cosmetics should be validated according to the criteria set in international guides. However, even if a method meets the defined validation criteria, it is possible that their performance is not good enough for products conformity evaluation. In this way, the goal of this project is to establish procedures for the performance evaluation of analytical methods based on measurement uncertainty. First, the measurement uncertainties associated with analytical methods will be estimated on the basis of validation results (accuracy and precision). The customers' and producers' risks will be estimated using Monte Carlo simulations, considering manufacturing processes with different capability scenarios. The analytical methods that present unsatisfactory performance will have their individual uncertainty sources identified and quantified in order to establish strategies for performance improvement, using the Analytical Quality by Design (AQbD) concepts. We hope that this project will enable the development of tools for assessing the performance of analytical methods usually employed by the pharmaceutical industry on conformity assessment of medicines and cosmetics. (AU)
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