MAFAR4300 Development and Manufacturing of Medicinal Products Course description

This course concerns preclinical aspects of the development and manufacturing of medicinal products, with a particular focus on biological drugs and radiopharmaceuticals, which the pharmaceutical industry must consider before a pharmaceutical product becomes available to the user. Important topics include the choice of lead compounds, mode of action, 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 explain the structural elucidation and structure-activity relationship of various pharmaceutical candidates
• can discuss especially expedient production and formulation strategies for biologics and radiopharmaceuticals
• can explain relevant analytical methods and molecular engineering used in the development and production of biological drugs
• can explain the requirements that apply to documentation of pharmaceutical quality (FDA/EMA) in connection with a marketing authorisation application

Skills

The student

• can critically assess and apply new knowledge about the structure-activity relationship of pharmaceuticals to develop new medicinal products
• can apply relevant legislation on quality assurance of the manufacturing, storage and distribution of medicinal products, with particular emphasis on biological drugs and radiopharmaceuticals
• can identify and elucidate the typical critical stages of the manufacturing and formulation of biological drugs and radiopharmaceuticals
• can apply methods for analysis and quality control of raw materials for biological drugs and radiopharmaceuticals, as well as ready-to-use medicinal products, and assess how deviations affect the quality of the final products

General competence

The student

• 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, 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 to assess relevant original articles related to drug development.

Studentene skal tilegne seg grunnleggende kunnskaper om webservere og utvikle ferdigheter og innsikt i full-stack programmering for web. Videre skal de utvikle ferdigheter og innsikt i programmering av dynamisk websider som kommuniserer med database. De skal også få kjennskap til informasjonssikkerhet i webdesign.

Ingen ut over opptakskrav.

Etter å ha gjennomført dette emnet har studenten følgende læringsutbytte, definert i kunnskap, ferdigheter og generell kompetanse:

Kunnskap

Studenten kan:

• forklare prinsipper for webarkitekturer og klient/tjener-arkitektur
• forklare ulike sikkerhetsutfordringer og hvordan disse kan håndteres
• gjøre rede for tilstandsbevaring via sessions og cookies
• forklare hensikten med og virkemåten til generiske datatyper

Ferdigheter

Studenten kan:

• utvikle dynamiske websider ved å beholde brukervennlighet og tilgjengelighet på høyt nivå.
• knytte dynamiske websider til en relasjonsdatabase
• benytte seg av Java Collections
• forstå virkemåten og bruken av rekursjon

Generell kompetanse

Studenten kan:

• utvikle objektorienterte programstrukturer i en webarkitektur
• utvikle et større dynamisk nettsted med persistent datalagring

Forelesninger og veiledningstimer. Studentene vil arbeide individuelt.

Følgende arbeidskrav er obligatorisk og må være godkjent for å fremstille seg til eksamen:

• en individuell oppgave

Individuell skriftlig eksamen under tilsyn på 3 timer

Eksamensresultatet kan påklages.