Glossary of Terms Useful in Biochemistry and Molecular Biology and Related Disciplines

Authored by: Roger L. Lundblad

Biochemistry and Molecular Biology Compendium

Print publication date:  June  2007
Online publication date:  June  2007

Print ISBN: 9781420043471
eBook ISBN: 9781420043488
Adobe ISBN:

10.1201/9781420043488.ch2

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Abstract

This document contains data that, when submitted to FDA’s Center for Drug Evaluation and Research (CDER), Office of Generic Drugs, provide for the review and ultimate approval of a generic drug product. This document does not contain preclinical or clinical data but must demonstrate that the drug in question is a bioequivalent to the currently licensed drug, which is also referred to as the innovator drug. See http://www.fda.gov/cder/drugsatfda/glossary.htm.

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