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EFSPI comments on FDA coveriate guideline collated
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EFSPI Comments on EMA Reflection paper on the use of extrapolation in the development of medicines for paediatrics |
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EFSPI Comments - ICH draft Concept Paper on choosing appropriate estimands in confirmatory clinical trials |
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EFSPI Comments - EMA draft guidance on 'Adjustement for Baseline Covariates' (EMA/295050/2013) |
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EFSPI comments on the EMA's Reflection paper on methodological issues associated with pharmacogenomic biomarkers |
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EFSPI comments on EMA 'Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available' |
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EFSPI comments on draft FDA 'Guidance for Industry – Adaptive Design Clinical Trials for Drugs and Biologics' |
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EFSPI comments on draft FDA 'Guidance for Industry - Non-Inferiority Clinical Trials' |
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EFSPI comments on EMEA CHMP guideline on missing data |
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EFSPI comments on EMEA CHMP guideline on the investigation of bioequivalence |