Radiopharmaceuticals Technology

Course guarantor:

Ján Kozempel

Lecturer:

Ján Kozempel, Martin Vlk

Tutor:

Supervisor:

Department of Nuclear Chemistry

Synopsis:

1.Research and development of radiopharmaceuticals, preclinical and clinial studies.

2.Raw materials and precursors of radiopharmaceuticals.

3.Specificity of radiopharmaceuticals preparation and production.

4.Sources of radionuclides, target systems and apparatuses (gaseous, liquid, solid), natural and enriched materials, their recycling.

5.Manipulation with high activities, biological shielding. Automated synthesisers (dedicated/universal, separation modules, microfluidic systems, proces parameters sensors, etc.).

6.Sterile and non-sterile preparations. Dispensing, formulation, sterilization and marking.

7.Pharmacopoeia and proces quality control methods of radiopharmaceuticals.

8.Processes validation, quality assurance and management systems, documentation.

9.Logistics of radiopharmaceuticals production.

10.Legislation requirements for radiopharmaceuticals preparation and production.

Requirements:

Students will prepare a seminar paper and a presentation on a given topic. The students work is assessed through an exam. A minimum success rate of 60% is required to pass the course.

Syllabus of lectures:

1.Research and development of radiopharmaceuticals, preclinical and clinial studies.

2.Raw materials and precursors of radiopharmaceuticals.

3.Specificity of radiopharmaceuticals preparation and production.

4.Sources of radionuclides, target systems and apparatuses (gaseous, liquid, solid), natural and enriched materials, their recycling.

5.Manipulation with high activities, biological shielding. Automated synthesisers (dedicated/universal, separation modules, microfluidic systems, proces parameters sensors, etc.).

6.Sterile and non-sterile preparations. Dispensing, formulation, sterilization and marking.

7.Pharmacopoeia and proces quality control methods of radiopharmaceuticals.

8.Processes validation, quality assurance and management systems, documentation.

9.Logistics of radiopharmaceuticals production.

10.Legislation requirements for radiopharmaceuticals preparation and production.

Syllabus of tutorials:

Study Objective:

Acquired knowledge:

Students learn basic aspects of radiopharmaceuticals production and preparation technology, the research, development and the introduction of novel radiopharmaceuticals, basic principles and rules of production under valid legislation.

Acquired skills:

The students gain knowledge in the technology of radiopharmaceuticals production and be able to design components of the production processes.

Study materials:

Key Literature:

1.Czech pharmacopoeia 2017, Grada Praha, ISBN: 859-404-924-045-6

2.Pharmaceuticals Act No.:378/2007 Coll., as amended

3.Act No.: 263/2016 Coll., atomic act, as amended

4.Decree No. 422/2016 Coll., on radiation protection and security of a radioactive source, as amended

Recommended Literature:

1.M. J. Welch, C. S. Redvanly: Handbook of Radiopharmaceuticals: Radiochemistry and Applications. John Wiley & Sons, 2003, ISBN: 0471495603

Note:

Time-table for winter semester 2025/2026:

Time-table is not available yet

Time-table for summer semester 2025/2026:

Time-table is not available yet

The course is a part of the following study plans:

• Jaderná chemie (compulsory elective course)