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Design of non-clinical and clinical safety or efficacy studies; Imaging system applications and approaches
We will help you with your study designs to maximize your results with respect to statistical power of the study, product appropriateness for dosing, animal model variables, appropriate imaging systems, radiotracers and contrast agents and biomarkers, and regulatory appropriateness for IND, NDA, BLA and device registrations.
Pharmacokinetic study designs, analyses, interpretation, and analytical hurdles and approaches. We have a history of PK and TK analyses, allometrics, and a specialty in the use and limits of image analysis for time rate of change parametric analyses.
Radiation Injury Animal Models, Decorporation and Dosimetry
Many years in radiobiology and the associated dosimetry of X-ray, Co-60, Cs-137 and LINAC systems and experience in radiotherapy including heavy-ion accelerated particle irradiation for Bragg Peak utilization in radiotherapy. Trace metal analysis and and elemental and radioisotope biodistribution and decorporation. .