MAFAR4300 Development and Manufacturing of Medicinal Products Course description

This course concerns different aspects of the development and manufacturing of medicinal products which the pharmaceutical industry must consider before a pharmaceutical product becomes available to the user. Important topics include the choice of lead compounds, pharmacological effect at conformation level, choice of formulation and documentation of pharmaceutical quality. ;

The student must have been admitted to the study programme.

After completing the course, the student should have the following overall learning outcomes defined in terms of knowledge, skills and general competence:

Knowledge

The student

• can discuss which pharmacodynamic and pharmacokinetic properties form the basis for choosing pharmaceutical candidates and how these properties can be changed and adapted during the process of developing the final new medicinal product
• can explain the structural elucidation and structure-activity relationship of various pharmaceutical candidates
• can discuss especially expedient production and formulation strategies for biologics and radiopharmaceuticals compared with chemical pharmaceuticals
• can explain the requirements that apply to documentation (FDA/EMA) in connection with; a marketing authorisation application for a medicinal product

Skills

The student

• can apply relevant legislation on quality assurance of the manufacturing, storage and distribution of medicinal products, with particular emphasis on radiopharmaceuticals
• can identify and elucidate the typical critical stages of the manufacturing and formulation of biologics compared with chemical pharmaceuticals
• can apply methods for analysis and quality control of radiopharmaceutical ingredients and products, and assess how deviations affect the quality of the final products

General competence

The student

• can critically assess and apply new knowledge about the structure-activity relationship of pharmaceuticals to develop new medicinal products
• can contribute to quality development in the manufacturing of medicinal products
• can contribute to the process of developing a medicinal product until the finished product has been marketed and meet the medical needs of society, at the national and international level, in a sustainable manner

Work and teaching methods include lectures, student-active seminars using the flipped classroom method, as well as project work and other group work. There will also be practical training in the laboratory.;Discussions about the course content with fellow students and teachers is emphasised.

For the project work, the students will work in groups on the development and/or improvement of the stages in the drug development process. ;

The following must have been approved in order for the student to take the exam:;

• Presentation of a project assignment in groups of 4-5 students

Supervised individual written exam, 5 hours.

None.

Grade scale A-F.

All exams are assessed by an internal and an external examiner.

None.