Autor: |
Temple RJ; Deputy Director for Clinical Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., O'Neill RT; Former Director of the Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Bethany, Delaward, USA., Peck CC; Department of Bioengineering and Therapeutic Sciences, University of California at San Francisco, San Francisco, California, USA.; NDA Partners, LLC, Rochelle, Virginia, USA. |