Course content

The course covers chemical principles and techniques relevant to drug development, drug production and bioanalysis. Central topics are synthesis, isolation and analysis of active pharmaceutical ingredients (API). Chemical strategies used throughout the "hit-to-lead-to-API" process are taught, with a link to both process quality, GMP production and documentation of pharmaceutical quality. Principles of structure-activity relationships and general "drug-likeness" in drug development and optimization are reviewed. Sample preparation, separation techniques and determination of drugs in biological material are taught, with emphasis on chromatographic principles, NMR and mass spectrometry.

Learning outcome

Knowledge

After completing the course, the student should

• Have in-depth knowledge of key chemical techniques used to identify, modify and optimize drug candidates in a development process.
• Have knowledge of the collection and preparation of biological material before chemical analysis.
• Have knowledge of analytical techniques used to quantify drugs in biological material.
• Have knowledge of the relationship between process development and impurity profiling in the development of API.

Skills

• After completing the course, the student can.
• Propose strategies for the development of API based on findings in screening experiments.
• Relate to impurity levels as development requirements.
• Propose strategies for sample preparation and analysis of drugs in biological material.
• Discuss results from bioassays.
• Set up protocols for validation of bioanalytical methods.

General competence

• After completing the course, the student will have an understanding of
• Which chemical principles underlie different development phases of new drugs.
• How chemical analyses are used to document the quality of drugs.
• How chemical analyses can contribute to more appropriate drug use.
• How bioassays are used in forensic toxicology/drug analyses.
• How the accuracy and precision of the methods affect the interpretation of analysis results.

Learning methods and activities

Lectures.

Specific conditions

Required previous knowledge

Admission to Master of Science in Pharmacy (MFARMASI) is required.

Course materials

Will be announced in the beginning of the semester.