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 drug. He/she will be able to understand and use the references (Pharmacopoeias, guidelines) related to the analysis of medicines. From there, he will be able to define the control strategy while having acquired notions of quality and validation which guarantee the quality of the pharmaceutical analysis.
The course objective is · to demonstrate the place and importance of quality control of medicines, · to discover the reference works and international standards, · to take a practical approach to the analytical techniques applied to medicines during their life cycle, · to finally be able to propose the quality control of a pharmaceutical form (raw materials and finished products)
The course will start with a reminder of the important notions acquired in the bachelor's degree course in Pharmaceutical Sciences. After having introduced the place of the analysis of the drugs, we will see the various references to be respected. We will then discuss the concepts of impurities and degradation products. The 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 notions of GMP, validation and qualification will help to understand the quality environment essential to pharmaceutical analysis. A personal work (or in group) will allow the student to put into practice (in a theoretical way) the analysis of drugs to a pharmaceutical speciality. A visit to a quality control laboratory will conclude this course. (visit to be confirmed according to Covid19 developments).
The examination will consist of a written assessment. An oral examination may be offered in addition to the written examination. Allocation of marks: Examination 16 out of 20 points and pharmaceutical specialty work (chap 11) 4 out of 20 points.