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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| Hauptverfasser: | , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2020
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| In: |
Journal of clinical pharmacology
Year: 2020, Jahrgang: 60, Heft: 10, Pages: 1294-1303 |
| ISSN: | 1552-4604 |
| DOI: | 10.1002/jcph.1622 |
| Online-Zugang: | 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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| Verfasserangaben: | Brit Silja Rohr and Gerd Mikus |
| Zusammenfassung: | 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. |
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| Beschreibung: | First published: 21 May 2020 Gesehen am 15.11.2021 |
| Beschreibung: | Online Resource |
| ISSN: | 1552-4604 |
| DOI: | 10.1002/jcph.1622 |