CDE, Inc. Dosimetry Services can speed the development of your diagnostic or therapeutic radiopharmaceutical, radiobiologic, or radiation emitting medical device. Time is money, and any decrease in development and/or regulatory approval process time can greatly improve the bottom line. Shorter development and regulatory approval times also improve the chances of being first to market with new products.
CDE designs study protocols for dosimetry data collection, performs image quantification, and produces final dosimetry estimates and reports for submission to IRBs and the FDA. CDE also performs custom radiation transport and kinetic modeling for dosimetry determination where no current models exist.
CDE understands the regulatory concerns of the FDA concerning dosimetry. CDE is the internal dosimetry consultant for the FDA (biologics). The principle dosimetrist Dr. Richard Sparks, has also served as the dosimetry consultant for CDER from 1994 to 1998.
Since 1997, CDE, Inc. Dosimetry Services has provided consulting services to speed the development and regulatory approval process to over 50 major pharmaceutical corporations and research centers. CDE staff has developed hundreds of dosimetry estimates for radiopharmaceuticals and medical devices, and published over 70 dosimetry related papers and/or abstracts.
Recently, CDE, Inc. spent 5 days in Toronto, Canada at the annual meeting of the Society of Nuclear Medicine.
Click here for pictures from the meeting.
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