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Scientific Writing

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Three Steps to Gauge Biosimilarity

Biosimilarity refers to the relationship between a proposed protein therapeutic (biologic) product and an approved reference product. Biosimilarity is similar to bioequivalence in proposed generic drugs in the small molecule…

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Food Effect Balance beam

How Food Interacts with Drugs in BA and BE Studies

This information is covered under Food and Drug Administration guidance titled, “Food-Effect Bioavailability and Fed Bioequivalence Studies.” Overview Food effect bioavailability (BA) studies and fed bioequivalence (BE) studies are both…

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