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| Company The name ABX is closely linked to the development of modern Molecular Imaging & Therapy. In 1996 ABX was first to provide quality precursor compounds to the Molecular Imaging community, allowing the development of industrial PET & SPECT radiopharmaceutical production. From an academic research method, Molecular Imaging has since grown into a standard diagnostic modality in clinical oncology and neuroscience. In 1998, recognising an unmet need for specialised development expertise for therapeutic radiopharmaceuticals, ABX additionally established its CRO division, which was involved in many important developments. Today,
 Molecular Therapy has become an accepted oncological treatment modality. ABX-CRO as an independent full service CRO was established in 2002. Due to its history, ABX-CRO has retained a strong focus in oncology, neuroscience, and imaging indications. Thanks to our special interdisciplinary set-up with a team of pharmacists, physicists, pharmacologists, imaging and regulatory experts, ABX-CRO successfully implements most unusual trials (e.g. imaging trials in psychiatric patients), with the same reliability as standard protocols. Our special services include: » PET studies in non-human primates » PET microdosing » Multicentre PET & SPECT studies » Pharmacodynamic fMRI studies » Molecular & functional Imaging Core Lab » 14C-ADME studies » Managed recruitment Organisation ABX-CRO is an independent international CRO, providing standard & specialised phase I – III services, with emphasis on neurosciences, oncology and diagnostic imaging. With a unique translational medicine approach, we take your product from the appropriate preclinical model, over Phase O microdosing, through to late stage development. ABX-CRO is based in Dresden, Germany, with global clinical coverage through local and cooperative offices in Australia, Brazil, France, Italy, Hungary, Japan, South Africa, Switzerland, and the US, and a network of home based pharmaceutical research experts. Local CRAs and regulatory expertise ensure fast study set-up and efficient monitoring. Central project management, administration, and quality assurance ensure even data quality and uniform documentation across different cultural environments. Our early phase operations in Germany implement advanced study types, such as oncological, multicentre or pharmacodynamic phase I studies, also for biologicals, radiopharmaceuticals, and HTPs (human tissue derived products). Our specialist radiopharmacy services and the physics department operate centrally from Dresden, Germany. |
Advanced Imaging for Drug Development Molecular Imaging with PET and SPECT, using established radiolabelled molecular probes, such as [18F]FDG, can identify efficacy of new cancer treatments much earlier than clinical parameters or conventional imaging with CT or MRI.  For CNS drug candidates, PET microdosing with [11C]-labelled drug analogues, is the method of choice to characterise drug properties in vivo in the relevant target species: man. Information on BBB penetration, receptor binding, or dose-response, enables rational decision-making early during development, minimising later attrition risk. Functional MRI (fMRI) permits non-invasive investigation of regional brain activation, based on regional perfusion and oxygen extraction. Activation patterns in health and disease states before and after pharmacological intervention can be quantitatively analysed and used to objectively assess subjective symptoms such as pain and anxiety, previously only amenable to rating scales. Such trials require close interaction of pharmacists, physicists, clinicians and statisticians, all the way through from study design, conduct until data analysis. Reflecting this, ABX-CRO overcomes the classical separation into clinical CRO and Image Core Lab, comprehensively integrating the scientific and medical expertise, required for advanced imaging trials. Whether an fMRI study investigating CNS effects, a multi-centre PET imaging solution, or a late stage therapy trial with imaging endpoints is needed, ABX-CRO provides the integrated solution from one stop. We look forward to discussing your project with you,  Dr. Andreas Kluge, General Manager |
 Dr. Andreas Kluge · General Manager |
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ABX-CRO's Quality Management System