Availability of stable isotope tracers for human use.
Stable isotope tracers do not have approval for diagnostic use in humans. We assume that stable isotope tracers behave like natural compounds, because there is no evidence for the opposite despite a wide use in human studies. From this point of view, they are drugs comparable to unlabelled natural substances. Under this assumption a pharmacy is allowed to prepare isotope solutions by following the guideline for the preparation of infusion solutions using chemicals. The pharmacy has to perform tests for identification, content and purity following the U.S. pharmacopoeia or the corresponding national standard for the unlabelled drug. If these tests are passed then it can prepare the tracer solution. An approach is outlined which is designed to ensure sterility of the preparation as far as possible and an adequate pharmaceutical quality. From the regulation for the preparation we define requirements for an alternative preparation for immediate infusion by the physician.
Vogt
J
J
Sekt. Anästhesiologische Pathophysiologie u. Verfahrensentwicklung, Ulm, Germany.
D006801:Humans; D007553:Isotope Labeling / Q000379:methods*; D007554:Isotopes; D013678:Technology, Pharmaceutical
D007554:Isotopes