Code: 15TRF Radiopharmaceuticals Technology
Lecturer: doc. RNDr. Ján Kozempel Ph.D. Weekly load: 2+0 Completion: EX
Department: 14115 Credits: 2 Semester: S
Description:
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.
Contents:
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.
Recommended literature:
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

Keywords:
radiopharmaceuticals, technology, medicines

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