Guideline to regulations for radiopharmaceuticals in early phase clinical trials in the EU.
The purpose of this guideline is to help investigators by giving an overview of relevant current EU requirements concerning the quality of starting materials and final drug products (the radiopharmaceuticals), the non-clinical safety studies and dosimetry considerations whilst designing a human clinical trial which includes the use of radiopharmaceutical compounds.
Verbruggen
Alfons
A
Laboratory of Radiopharmacy, Onderwijs en Navorsing 2, Box 821, Herestraat 49, 3000, Leuven, Belgium. Alfons.Verbruggen@pharm.kuleuven.be
Coenen
Heinz H
HH
Deverre
Jean-Robert
JR
Guilloteau
Denis
D
Langstrom
Bengt
B
Salvadori
Piero A
PA
Halldin
Christer
C
D002986:Clinical Trials as Topic / Q000592:standards*; D005062:European Union; D019788:Fluorodeoxyglucose F18 / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D011874:Radiometry; D019275:Radiopharmaceuticals / Q000009:adverse effects / Q000592:standards* / Q000627:therapeutic use; D013669:Technetium Tc 99m Medronate / Q000009:adverse effects / Q000627:therapeutic use
D019275:Radiopharmaceuticals; D019788:Fluorodeoxyglucose F18; D013669:Technetium Tc 99m Medronate