TY - JOUR
T1 - Radiopharmacy
T2 - Regulations and legislations in relation to human applications
AU - Decristoforo, Clemens
AU - Schwarz, Sally W.
PY - 2011
Y1 - 2011
N2 - Radiopharmaceuticals (RPs) have attracted tremendous interest as molecular imaging tracers in diagnostic applications and as biomarkers in drug development, in particular using Positron Emission Tomography (PET). This article summarizes important legal documents and guidelines in relation to human application of PET-RPs that pose a major challenge in implementing the full potential of this technology, thereby differentiating the US from the European situation. Regulations are reviewed with respect to licensing, conducting clinical trials and RP production - including Good Manufacturing Practice (GMP) for radioactive compounds. Professional requirements, including education, are discussed, with an outlook on future developments.
AB - Radiopharmaceuticals (RPs) have attracted tremendous interest as molecular imaging tracers in diagnostic applications and as biomarkers in drug development, in particular using Positron Emission Tomography (PET). This article summarizes important legal documents and guidelines in relation to human application of PET-RPs that pose a major challenge in implementing the full potential of this technology, thereby differentiating the US from the European situation. Regulations are reviewed with respect to licensing, conducting clinical trials and RP production - including Good Manufacturing Practice (GMP) for radioactive compounds. Professional requirements, including education, are discussed, with an outlook on future developments.
UR - http://www.scopus.com/inward/record.url?scp=84861230380&partnerID=8YFLogxK
U2 - 10.1016/j.ddtec.2011.11.012
DO - 10.1016/j.ddtec.2011.11.012
M3 - Review article
C2 - 24990265
AN - SCOPUS:84861230380
SN - 1740-6749
VL - 8
SP - e71-e77
JO - Drug Discovery Today: Technologies
JF - Drug Discovery Today: Technologies
IS - 2-4
ER -