Proposal of a safe and effective study design for CYP3A-mediated drug-drug interactions

Numerous drug-drug interaction (DDI) trials have to be conducted in healthy volunteers based on current regulatory guidelines. Because the worst-case scenario of strong cytochrome P450 (CYP) inhibitors has to be tested, the results and their validity have to be balanced with the risk to volunteer sa...

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Bibliographic Details
Main Authors: Rohr, Brit Silja (Author) , Mikus, Gerd (Author)
Format: Article (Journal)
Language:English
Published: 2020
In: Journal of clinical pharmacology
Year: 2020, Volume: 60, Issue: 10, Pages: 1294-1303
ISSN:1552-4604
DOI:10.1002/jcph.1622
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1002/jcph.1622
Verlag, kostenfrei, Volltext: https://accp1.onlinelibrary.wiley.com/doi/10.1002/jcph.1622
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Author Notes:Brit Silja Rohr and Gerd Mikus
Description
Summary:Numerous drug-drug interaction (DDI) trials have to be conducted in healthy volunteers based on current regulatory guidelines. Because the worst-case scenario of strong cytochrome P450 (CYP) inhibitors has to be tested, the results and their validity have to be balanced with the risk to volunteer safety.
Item Description:First published: 21 May 2020
Gesehen am 15.11.2021
Physical Description:Online Resource
ISSN:1552-4604
DOI:10.1002/jcph.1622