Role of Phase 0 trials in drug development
Phase 0 trials can provide proof of concept that an agent modulates its intended target without exposing patients to the drug-tolerability testing that precedes efficacy evaluation. Drugs that do not modulate their targets can be discarded, focusing development resources on the most clinically promising agents. However, wider uptake of Phase 0 trials may be hindered by ethical concerns over their lack of therapeutic intent, the substantial resources required to develop and validate target assays or skepticism that such trials save development time.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2009 |
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| Erschienen: |
2009 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:1 |
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| Enthalten in: |
Future medicinal chemistry - 1(2009), 8 vom: 01. Nov., Seite 1375-80 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Doroshow, James H [VerfasserIn] |
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| Links: |
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| Themen: |
01O4K0631N |
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| Anmerkungen: |
Date Completed 01.07.2011 Date Revised 03.04.2015 published: Print Citation Status MEDLINE |
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| doi: |
10.4155/fmc.09.117 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM206842880 |
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