Delay in the FDA approval process can be extremely costly. When large sums of money are tied up in the development of a new radiopharmaceutical, a six month delay based on a request for additional information from the FDA can cost hundreds of thousands or even millions of dollars from lost investment opportunities alone. Pre submission review by CDE can catch and correct dosimetry related problems help to greatly lessen the probability of such an occurrence.
CDE will review all aspects of your dosimetry submission to insure proper data collection, region of interest completeness, suitable image quantification methodology, appropriate bio-kinetic modeling, proper physics modeling, correct special organ/tissue dosimetry model application, and report completeness.
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