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A procedure for auditing radiopharmaceutical formulations is described. To meet FDA guidelines regarding the quality of radiopharmaceuticals, institutional radioactive drug research committees perform audits when such drugs are formulated away from an institutional pharmacy. All principal investigators who formulate drugs outside institutional pharmacies must pass these audits before they can obtain a radiopharmaceutical investigation permit. The audit team meets with the individual who performs the formulation at the site of drug preparation to verify that drug formulations meet identity, strength, quality, and purity standards; are uniform and reproducible; and are sterile and pyrogen free. This team must contain an expert knowledgeable in the preparation of radioactive drugs; a radiopharmacist is the most qualified person for this role. Problems that have been identified by audits include lack of sterility and apyrogenicity testing, formulations that are open to the laboratory environment, failure to use pharmaceutical-grade chemicals, inadequate quality control methods or records, inadequate training of the person preparing the drug, and improper unit dose preparation. Investigational radiopharmaceutical formulations, including nonradiolabeled drugs, must be audited before they are administered to humans. A properly trained pharmacist should be a member of the audit team.

Efficient control over the purchase and receipt of radioactive material is a necessary part of any radiation safety program. We describe a novel computerized method for monitoring the flow of radioactive material within a large broad-licensed medical research complex. The Local Area Network (LAN) described interfaces the radiation safety office with radionuclide receiving, the authorized user, grants and contracts, special accounts, and purchasing. Task-specific software enables the authorized user to place an order and allows the monitoring of possession/ordering limits, personnel, date of order, and time of receipt via the screen. The resultant data base is easily annexed for specific information. The system is user-friendly and adaptable to any set of circumstances.

The biodistribution, kinetics, imaging characteristics and blood flow correlations of 99mTc labeled DiArs and DMPE were studied. The mice biodistribution were compared to 201Tl in mice and dogs, respectively. The myocardial kinetics of these agents were evaluated in normal and ischemic myocardium using miniaturized endocardial detectors. DiArs had a lower myocardial concentration (9.4 +/- 0.8% dose/g at 1 min), than DMPE (11.7 +/- 1.1% dose/g at 1 min) but both were considerably less than 201Tl (23-26% dose/g at 1 min). The kinetic characteristic of both technetium labeled agents suggested that redistribution into ischemic myocardium would not take place, since the clearance rate from normal and ischemic myocardium was similar for both the DiArs and DMPE . The clear visualization of the canine myocardium after i.v. injection demonstrated the superiority of DMPE over DiArs and the potential use of these agents, if proven, to behave the same in human trials.