Question

28) Mo- 29 82Sr → . 3) Submission of an IND or approval by a RDRC are two means by which an investigational clinical trial is allowed with an experimental radiopharmaceutical in the U.S. by which Federal agency? Briefly describe what types of information must be inluded in these documents to gain approval for a first in human investigation for any new or novel radiopharmaceutical. Select a PET procedure and briefly describe the nuclear reaction used to make the imaging isotope, it's half life and how the radiopharmaceutical is made and then used and administered to produce the image and how the image is used to make a clinical evaluation. 32)

Answer 1

linica28) ⁹⁹Mo $\rightarrow$ ^99MTc

29) ⁸²Sr $\rightarrow$ ⁸²Rb

30)^113mIn $\rightarrow$ ¹¹³In

31) An investigational clinical trial of an experimental radiopharmaceutical cannot be directly distributed directly into the market without approval from the responsible agency. The new/investigational clinical trial of a radiopharmaceutical clinical trial will be promoted neither by an investigator or the sponsor for its application in humans. It needs a prolonged process of investigation need to be reached at whether the drug is safe and effective. If the drug is found to be safe and effective that needs strong evidence. With the strong evidence, the drug is found to be safe and effective they have to get approval from the FDA or the U.S Food and Drug Administration is being provided for treatment use.

*After a clinical trial of an experimental radiopharmaceutical, it may be considered as "new".The application of the new clinical trial to be used in humans according to to the U.S Food and Drug Administration regulations the clinical trial has to get FDA approval.

The new use of the drug would be considered as investigational.

An investigational new cannot be directly distributed after their clinical trial. For the distribution it as commercially they need first the approval.

After the clinical trial of an experimental radiopharmaceutical, these investigational new drugs are regulated under 21 CFR 312.

Labeling of the drug with the following statement "Caution".

An IND is considered safe to proceed 30 calendar days after the FDA receives it.

32) Nuclear medicine is performed via the administration of various radiopharmaceuticals to the patient with subsequent recording of in vivo distribution.

Fluorodeoxyglucose is a radionuclide decay rapidly, with half-lives of only minutes to hours. It is administered or used for the diagnostic purpose in conjunction with PET

In the Positron Emission Tomography creates tomographic images by detecting gamma rays produced when positrons and electrons collide.

Here we can go for a skeletal study to evaluate for early bone metastases, and/or primary bone neoplasms

It is particularly useful to diagnose or stage tumors, evaluate dementia, monitor for tumor recurrence, track post-therapy changes, and evaluate myocardial viability

Thus the Radiologic images will be helpful in :

#Diagnosis

#Staging

#Improvement

#Surveillance

#Therapy