Orientation and Training
Food and Drug Administration
The trainer will provide the training, e.g. reading, demonstrations, self-study, on the job training. Assigned radiopharmaceuticals will be dependent on Center/CDER initiatives or requests.
The trainee will read the ORA Laboratory Manual, Volume IV, Section 3: Drug Analysis.
The USP/NDA methods for radiopharmaceuticals include conventional pharmaceutical analyses and may include the following:
- assay for radioactivity,
- radiochemical purity,
- radionuclidic purity, and
- radionuclide identification.
- Define radiochemical purity and radionuclidic purity.
- Define the term “cold kit.” Define precautions are to be taken when preparing a cold kit with Tc-99m? What happens when air is inadvertently introduced into the cold kit?
- Discuss the theory of operation and use of Tc-99m/Mo-99 generator.
- United States pharmacopoeia and national formulary (current ed.).
- ORA Laboratory Manual, Volume IV, Section 3: Drug Analysis.