Preparation and quality control
Preparation of the drug should be simple and require relatively little manipulation on the part of the preparer. Procedures with more than 3 steps generally do not meet this requirement. In addition, no complicated equipment or time consuming steps should be involved.
If radiopharmaceuticals are manufactured in-house, it is essential that quality control be performed on every batch of drug prepared to insure that each individual preparation that will produce the appropriate level of therapy while minimizing the radiation dose to the patient. Altered biodistribution caused by an improperly prepared drug can confer very high radiation dose to undesired locations.
Criterion: One must be able to answer "YES" to the question, "Would I inject this into my mother?" Without performing quality control testing, it's impossible to know how well the product will perform.
|Stephen Karesh, PhD.||
Last Updated: August 14, 1996