PET - Tracer production
7 important questions on PET - Tracer production
You can bombard the target with different particles. Which ones?
What is [11C]SMW139? In which animals used?
- Experimental autoimmune encephalomyelitis (EAE) multiple sclerosis mouse models are standard models for brain inflammation and demyelination studies.
When you want to give a human 100 microgram, how much would you have to give to animals in your experiments?
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What do you need to do before human application (5)
- Follow regulations:
GMP = good manufacturing practice
- You need reliable chemistry
- GMP improves on manufacturing license
- Dosimetry estimate: Toxicology studies > 1000 times the dose
- Medical ethical committee approval
Name some facts about microdosing toxicity studies. (7)
- 1000 fold larger dose
- done in rodents
- both in female and male
- You need 5 animals per timepoints
- You need at least 2 timepoints (1 and 14 days post injection)
- Assess clinical chemistry ex vivo; during the first two week vital signs
- You have to execute it in a lab with GLP (good laboratory practice)
How can you doe tracer validation? (first human study)
2. Control group
3. Dynamic scanning => 90 minutes, the more data the better
4 use metabolic analysis in arterial blood
5. Quantification => make sure that the amount is right
6. Very reproducible, variety in result is very small so you don’t need a lot of patients.
What is difficult in study logistics?
- Cannot do a stability test for weeks => because of the half-life.
- Injected iv => so it must be sterile => but there is no time to test that. So you must work in a clean room. Everything is strictly regulated.
- Everything is time dependent: You are happy if you have 1% injected.
- The purification needs to be short: test if there was no contamination, purity test, sterility test etc.
The question on the page originate from the summary of the following study material:
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