Innovative methods for rare disease drug development
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| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Boca Raton
Chapman & Hall/CRC
2020
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| Ausgabe: | 1st edition |
| Schriftenreihe: | Chapman & Hall/CRC biostatistics series
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| Schlagworte: | |
| Online-Zugang: | TUM01 |
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| Beschreibung: | <P>Preface. 1. Introduction. 2. Basic Considerations. 3. Hypotheses Testing for Clinical Evaluation. 4. Endpoint Selection in Clinical Trials. 5. Strategy for Margin Selection. 6. Probability of Inconclusiveness. 7. Probability Monitoring Procedure for Sample Size. 8. Real-World Data and Real-World Evidence. 9. Innovative Approaches for Rare Diseases Drug Development. 10. The <EM>n</EM>-of-1 Trial Design and Its Application. 11. Two-Stage Adaptive Seamless Trial Design. 12. Master Protocol -- Platform Trial Design. 13. Gene Therapy for Rare Diseases. 14. Clinical Development for NASH Program</P> |
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| Beschreibung: | 1 Online-Ressource () illustrations (black and white) |
| ISBN: | 9781000208337 1000208338 9781000208214 1000208214 9781000208276 1000208273 9781003049364 1003049362 |