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CZECH TECHNICAL UNIVERSITY IN PRAGUE
STUDY PLANS
2019/2020

Radiopharmaceuticals Technology

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Code Completion Credits Range
15TRF ZK 2 2+0
Lecturer:
Martin Vlk, Ján Kozempel (guarantor)
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:

Profound knowledge of inorganic and organic chemistry, synthesis, chemical analytical and radio-analytical methods

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:

Compulsory literature:

1. Czech pharmacopoeia 2009 ? suppl. 2015, Grada Praha, ISBN: 978-80-247-5522-9.

2. Pharmaceuticals Act No.:378/2007 Coll.

3. Act No.: 18/1997 Coll., on the peacefull utilization of nuclear energy and ionizing radiation.

4. Decision of The State Office for Nuclear Safety No.: 307/2002 Coll., on radiation protection.

Optional literature:

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

2. Komárek P., Rabišková M. a kol.: Technologie léků. 3. vydání, 2006, Galén, Praha, ISBN: 8072624237.

Note:
Time-table for winter semester 2019/2020:
Time-table is not available yet
Time-table for summer semester 2019/2020:
Time-table is not available yet
The course is a part of the following study plans:
Data valid to 2020-04-08
For updated information see http://bilakniha.cvut.cz/en/predmet4997406.html