Inhaltsangabe
Preface 1.Foreword 2.New Drug Development 3.The Regulatory Environment 4.Drug Discovery 5.Nonclinical Research 6.Designing Clinical Trials 7.Conducting Clinical Trials I: Experimental Methodology 8.Conducting Clinical Trials Ii: Operational Execution 9.Statistical Analysis 10.Statistical Significance 11.Clinical Significance 12.Sample-Size Estimation 13.General Safety Assessments 14.Efficacy Assessment 15.Cardiac And Cardiovascular Safety Assessments 16.Manufacturing Small-Molecule Drugs And Biologicals 17.Postmarketing Surveillance 18.Main Themes And Concluding Comments Reference List Index
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