Scientific considerations for global drug development
Copyright © 2020 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works..
Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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| Enthalten in: |
Science translational medicine - 12(2020), 554 vom: 29. Juli |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Wilson, Jennifer L [VerfasserIn] |
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| Links: |
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| Themen: |
Journal Article |
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| Anmerkungen: |
Date Completed 23.06.2021 Date Revised 23.06.2021 published: Print Citation Status MEDLINE |
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| doi: |
10.1126/scitranslmed.aax2550 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM313035350 |
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| 520 | |a Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies | ||
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| 700 | 1 | |a Porrás, Analia I |e verfasserin |4 aut | |
| 700 | 1 | |a Zou, Ling |e verfasserin |4 aut | |
| 700 | 1 | |a Mukanga, David |e verfasserin |4 aut | |
| 700 | 1 | |a Akpa, Paul A |e verfasserin |4 aut | |
| 700 | 1 | |a Darko, Delese Mimi |e verfasserin |4 aut | |
| 700 | 1 | |a Yuan, Rae |e verfasserin |4 aut | |
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| 700 | 1 | |a Giacomini, Kathleen M |e verfasserin |4 aut | |
| 700 | 1 | |a Blaschke, Terrence F |e verfasserin |4 aut | |
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