[The clinical quality evaluation of radiopharmaceutical preparations for diagnostic use].
The authors issued some recommendations for assessment of new radiopharmaceuticals (RP) at the stage of clinical trials. The most decisive thing is to determine the clinico-diagnostic efficacy of a radiopharmaceutical and its safety. Direct extrapolation of the results of experimental investigation of biodistribution of labeled compounds on man was shown to be fraught with serious errors. Differences in RP pharmacokinetics necessitate a planned, methodologically correct and clinically substantiated study of a RP in selected groups of patients taking into account the functional purpose of a drug. The assessment of RP quality is based upon a study of functional suitableness resulting from pharmacokinetic data and the determination of optimum methodological conditions and safety of a new RP, including the calculation of radiation a patient is exposed to during a diagnostic procedure. The stages of clinical trials are given in detail, their unification is aimed at raising their quality and improved clinical assessment of a RP.
Korsunskiĭ
V N
VN
Tarasenko
Iu I
IuI
Tuktaev
A V
AV
D002986:Clinical Trials as Topic / Q000379:methods; D006801:Humans; D011786:Quality Control; D011829:Radiation Dosage; D011868:Radioisotopes / Q000009:adverse effects / Q000493:pharmacokinetics / Q000592:standards*; D011877:Radionuclide Imaging / Q000592:standards
D011868:Radioisotopes
Klinicheskaia otsenka kachestva RFP diagnosticheskogo naznacheniia.