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Guidance for Industry

. US Department of Health and Human Services FDA (CDER) and (CVM), (2001)

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Adaptive Designs for Clinical Trials of Drugs and Biologics - Guidance for Industry. (2018)Disseny; Dissenys adaptatius; Regulació.Guidance for Industry. US Department of Health and Human Services FDA (CDER) and (CVM), (2001)General Principles of Software Validation. Final Guidance for Industry and FDA Staff, U.S. Food and Drug Administration, (January 2002)