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FDA's Drug Review Process and the Package Label by Tom Brody

Author:Tom Brody , Date: March 4, 2020 ,Views: 308

FDA's Drug Review Process and the Package Label by Tom Brody

Author:Tom Brody
Language: eng
Format: epub
ISBN: 9780128146484
Publisher: Elsevier Ltd.
Published: 2018-03-03T16:00:00+00:00


Chapter 8

Drug–Drug Interactions

Part Two (Therapeutic Proteins)

Abstract

This chapter concerns drugs that are therapeutic proteins, and drug–drug interactions (DDIs) involving therapeutic proteins. Therapeutic proteins take the form of recombinant antibodies, recombinant enzymes, recombinant hormones, and recombinant cytokines. DDIs involving only small molecule drugs involve studying the interaction of a first small molecule drug with a second small molecule drug. But DDIs with therapeutic proteins involve studying the interaction of the therapeutic protein with a small molecule drug. One example of this type of DDI is where the therapeutic protein changes the level of cytochrome P450 (CYP enzyme) in the liver, where this change in the CYP enzyme has an effect on the coadministered small molecule drug.



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