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Does the FDA Owe Us an Explanation?

In the U.S., approval of generic congeners of branded drugs requires bioequivalence. (1) Bioequivalence is determined by serum concentration parameters (e.g., area under the curve, peak concentrations) within a defined range of those obtained with the parent proprietary compound. No clinical testing of outcomes, tolerance, etc. are necessary.

Credits: James A. Reiffel

Biosense Webster
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Introduction to AFib
Ablation Specialist

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