Phase 0 studies, also called micro-dosing studies, are a new regulatory category, guided by the EMEA (CPMP/SWP/2599/02, 2003) and FDA (Exploratory IND draft, 2005) allowing to perform human studies with a considerably reduced tox package, compared to a conventional first in human study, provided that not more than 100 µg substance are administered.
For CNS drug candidates, microdosing is of special interest to investigate BBB penetration, receptor binding, or dose-to-target-organ relationships. Also, first evidence on metabolism can be obtained. Microdosing represents a considerable cost and time advantage and helps to minimise attrition rates in CNS compound development.
|ABX-CRO offers different PET study types
Pharmacokinetic PET studies
PET studies using radioanalogues of NCEs labelled with 11carbon allow to quantitatively assess pharmacokinetics and metabolism. In combination with behavioural, clinical or paraclinical data, pharmacokinetic PET studies allow the establishment of dose-efficacy relationships and dose finding.
Pharmacodynamic PET studies
PET studies using cold NCEs in combination with established radiotracers allow to assess pharmacodynamic properties. Using metabolic tracers such as e.g. [18F]FDG, drug effects on metabolism can be studied. Using [11C]-labelled standard ligands to a target molecule, receptor binding properties of the NCE can be assessed in vivo by displacement studies.
PET tracer development studies
For PET radiopharmaceuticals to be developed as diagnostic products in their own right, ABX-CRO performs integrated development programmes from preclinical through to registration.
» Strategy consultancy
» Custom labelling (11C, 18F, 68Ga)
» Radiopharmacology & dosimetry
» Human dosimetry
» Advanced data analysis
- Kinetic modelling
- Receptor occupancy
» Full service projects