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Phase 0 Microdosing Studies
CRST’s clinical research services are focused on the early phases of clinical drug development. We offer Phase 0 microdosing studies to allow drug developers to confidently select the most promising compounds for clinical development.
Phase 0 microdosing studies obtain the preliminary pharmacokinetic and metabolic data on a set of drug candidates with limited preclinical safety data and a small number of subjects. In microdosing studies, the dose administered is typically very small, about 1/100th of the proposed pharmacologic dose. Early human pharmacokinetic proof of concept can be derived from a microdosing study with 14C labelled compounds. Their analysis is by accelerator mass spectrometry (AMS) which allows the detection of such trace amounts.
In addition, CRST is able to conduct studies using PET imaging in Phase 0. Due to our long standing collaboration with the Radiochemistry Laboratory of Turku PET Centre, we are able to employ novel PET tracers as research tools.
CRST understands the importance of early phases in clinical drug development and our team is dedicated to providing a fully comprehensive regulatory and clinical service package for Phase 0/Microdosing Studies. Our package includes:
• Medical and scientific consultation
• Study design planning
• Medical writing: protocol, informed consent and other required documents, study report, translations
• Regulatory submissions: preparation of documents, submissions and correspondence with the Finnish Medicines Agency (Fimea) and the Ethics Committee
• CRF and source data form design
• Subject recruitment
• Clinical conduct of the study
• Study monitoring
• Project and site management
For more information or to discuss phase 0 microdosing studies please contact us directly.