At the end of the course, the student will be familiar with the analytical techniques applied to the pharmaceutical world throughout the life cycle of a medicinal product.
They will be able to understand and use standards (pharmacopoeias, guidelines) relating to the analysis of medicinal products.
From there, they will be able to define the control strategy while having acquired notions of quality and validation that guarantee the quality of pharmaceutical analysis.
The student will be familiar with the essential aspects of the ISO-15189 standard for clinical biology laboratories, including in particular :
Laboratory quality control.
Uncertainty of measurement for the interpretation of results.
Biological variation and its impact on quality objectives.
The student will also be able to:
Be critical of the performance of diagnostic tests, whether performed in the laboratory or sold in pharmacies.
Understand aspects of biological variation and their impact on quality objectives.
The course objective is
- to demonstrate the place and importance of quality control of medicinal products,
- to discover the reference works and international standards,
- take a practical approach to the analytical techniques applied to medicinal products throughout their life cycle,
- to finally be able to propose the quality control of a pharmaceutical form (raw materials and finished products).
Also:
Quality control: demonstrating the place and importance of quality control in a clinical biology laboratory.
Uncertainty and biological variation: understand the importance of measurement uncertainty and biological variation for the interpretation of results.
Diagnostic test performance: assessing test performance and remaining critical of results obtained in the laboratory or in the pharmacy.
The course will begin with a reminder of the important notions acquired in the bachelor's degree courses in Pharmaceutical Sciences. After introducing the role of drug analysis, we will look at the various standards to be met. We will then look at the concepts of impurities and degradation products. Analytical techniques applied to pharmaceutical substances and drugs will be reviewed. The analysis of drugs in biological media will be discussed in the context of toxicological and clinical studies (Phase I, II and III). The concepts of GMP, validation and qualification will provide an understanding of the quality environment essential to pharmaceutical analysis. Personal (or group) work will enable students to put into practice (theoretically) the analysis of drugs in a pharmaceutical speciality. A visit to a quality control laboratory will complete this course.
Also:
Key points of the ISO-15189 standard with an impact on results and their interpretation, including laboratory quality control.
Measurement uncertainty and biological variation: basic concepts and acceptability criteria.
Diagnostic test performance: methods for assessing accuracy, sensitivity and specificity, and for interpreting results critically.
The courses are given ex cathedra. Students are provided with written materials that cover the material covered in the course.
| Training | Study programme | Block | Credits | Mandatory |
|---|---|---|---|---|
| Master in Pharmacy, Professional focus | Standard | 0 | 4 | |
| Master in Pharmacy, Research focus | Standard | 0 | 4 | |
| Master in Pharmacy, Professional focus | Standard | 1 | 4 | |
| Master in Pharmacy, Research focus | Standard | 1 | 4 |