Methodological developments vs. regulatory requirements (Q5122847)
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scientific article; zbMATH DE number 7251471
| Language | Label | Description | Also known as |
|---|---|---|---|
| default for all languages | No label defined |
||
| English | Methodological developments vs. regulatory requirements |
scientific article; zbMATH DE number 7251471 |
Statements
Methodological Developments vs. Regulatory Requirements (English)
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24 September 2020
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adaptive designs
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adaptive information design
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adaptive study designs
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biostatistics
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clinical trial simulation
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dropping a treatment arm
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drug safety
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estimation
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experimental design
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FDA critical path
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guidance development
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multiple endpoints
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non-inferiority trials
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phase III clinical trials
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quantitative risk/safety assessment
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regulatory biostatistics
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regulatory evaluation
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sample size reassessment
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statistical efficiency
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statistical information
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superiority
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0.9580604434013368
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0.9483490586280824
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0.937932789325714
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0.8905978798866272
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