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Does the requirement of a range of +/- 20% for dose apply to both therapeutic and diagnostic dose?

April 26, 2017diagnostic dose range requirement therapeutic

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Does the requirement of a range of +/- 20% for dose apply to both therapeutic and diagnostic dose?

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Yes, under 64E-5.616, FAC, the dosage range applies to all unsealed byproduct material for medical use. An AU may prescribe a dosage or a dosage range. The permitted variation for an administered dose when an AU has not prescribed a dosage is a dosage range +/- 20%.