Analytical Methods Validation

Recommended Prerequisites

Knowledge in statistics.   

Teaching Methods

1. Theoretical transmission of knowledge and interaction with students on some crutial subjects and / or procedures.

2. Theoretical-practical with some concrete cases - applications in the statistical treatment of the data using spreadsheets.

3. Mini-research project to promote the student's ability in the analysis and synthesis of issues. The presentation of these projects to the class is still a stimulating and oral transmission of knowledge.  

Learning Outcomes

It is intended that students acquire skills in Chemical Quality Control at the Characterization and Validation of

Analytical Methods:

1. performance parameters of Analytical Methods;

2. purpose of validation;

3. statistically based decision making.  

Work Placement(s)

No

Syllabus

1. introduction

2. Statistical data treatment

3. The uncertainty in measurement *

4. Characterization of the analytic method *

5. Validation of analytical methods *       

Head Lecturer(s)

Jorge Luís Gabriel Ferreira da Silva Costa Pereira

Assessment Methods

Assessment
Synthesis work: 10.0%
Resolution Problems: 10.0%
Project: 30.0%
Exam: 50.0%

Bibliography

1. L. Huber,Validation and qualification in analytical laboratories,Informa Healthcare, New York, 2nd Ed,2007
2. C.C. Chan et al., Analytical Method Validation and Instrument Performance Verification, Wiley, New Jersey,2004
3. J. Ermer, J.H. McB. Miller, Validation of Analytical Methods for Pharmaceutical Analysis, Wiley-VCH, Weinheim,2005
4. J.N. Miller, J.C. Miller, Statistics and chemometrics for analytical chemistry, Prentice Hall,Harlow,2010, 6th. Ed

5. B. Magnusson, U. Örnemark, Eurachem guide: The fitness for purpose of analytical methods. A laboratory guide to method validation and related topics, 2nd Ed., 2014
6. S.L.R. Ellison, A. Williams, Quantifying Uncertainty in Analytical Measurement, Eurachem-CITAC Guide CG 4, 3rd Ed, Eurachem-CITAC,2012
7. M.E. Swartz, I.S. Krull, Analytical method development and validation, Marcel Dekker, NewYork,1997
8. D.L. Massart et al, Chemometrics, a text book, Data handling in science and technology, vol.2, Elsevier, Amsterdam,1988