Harmonization of United States, European Union and Canadian First-in-Human Regulatory Requirements for Radiopharmaceuticals-Is This Possible?

In recent years, several new radiotracers and radionuclide therapies have been developed. There is a renaissance in nuclear medicine and molecular imaging today, for example, in terms of the ability to image and treat neuroendocrine and prostate malignancies. In order to be able to bring a new drug product from bench to bedside and assist patients, while also ensuring patient safety, stringent regulations must be met.

ASSESSMENT OF EFFECTIVE DOSE FROM CONE BEAM CT IMAGING IN SPECT/CT EXAMINATION IN COMPARISON WITH OTHER MODALITIES.

The aim of this study was to assess radiation dose from the cone beam computed tomography (CBCT) component of single photon emission tomography/computed tomography (SPECT/CT) examinations and to compare it with the radiopharmaceutical related dose as well as dose from multidetector computed tomography (MDCT). Effective dose (ED) from computed tomography (CT) was estimated using dose-length product values and anatomy-specific conversion factors. The contribution from the SPECT component was evaluated using ED per unit administered activity for the radiopharmaceuticals listed in the International Commission on Radiological Protection Publications 80 and 106.

JOURNAL CLUB: CT dose optimization for whole-body PET/CT examinations.

OBJECTIVE. The objective of this study was to optimize CT protocols for whole-body PET/CT by reducing radiation dose while minimizing effects on image quality. MATERIALS AND METHODS.

Microsatellite markers in the western prairie fringed orchid, Platanthera praeclara (Orchidaceae).

Premise Of The Study: Primers for 31 microsatellite-containing loci were developed for the threatened orchid Platanthera praeclara to enable characterization of the population genetics of this tallgrass prairie native. •

Methods And Results: Sixteen polymorphic microsatellite loci were identified from four populations. Six of these loci were not in linkage disequilibrium.

The establishment of genetically engineered canola populations in the U.S.

Concerns regarding the commercial release of genetically engineered (GE) crops include naturalization, introgression to sexually compatible relatives and the transfer of beneficial traits to native and weedy species through hybridization. To date there have been few documented reports of escape leading some researchers to question the environmental risks of biotech products. In this study we conducted a systematic roadside survey of canola (Brassica napus) populations growing outside of cultivation in North Dakota, USA, the dominant canola growing region in the U.