Theory of Drug Development

Theory of Drug Development

Holmgren, Eric B.

Taylor & Francis Ltd

09/2018

261

Mole

Inglês

9781138374683

15 a 20 dias

490

Descrição não disponível.
A Theory of Evaluating Drugs: Clinical Drug Development Phases 1 through 3. Choosing Drugs to Develop. Phase 2/3 Strategy. Maximize the Minimum Efficiency. Single-Arm Phase 2 Trial. Phase 2 Trials Based on Surrogate Endpoints. Dose Selection and Subgroups: Phase 2 as a Pilot Trial. Multistage Screening. A Theory of Evidence in Drug Development: Preference for Simple Tests of Hypotheses over Model-Based Tests. Quantifying the Strength of Evidence from a Study. Quantifying the Strength of Evidence: A Few Additional Comments on Interim Analyses. Confirmatory Trials. Additional Topics: Maximize Efficiency Subject to a Constraint on True+/False+. Power of the Log Rank Test to Detect Improvement in Mean Survival Time and the Impact of Censoring. Adaptive Phase 2/3 Designs. Size of the Phase 3 Trial Extending the Model of Clinical Drug Development. Appendices.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Tr Ue;Relative Efficiency Increases;treatment;Interim Analysis;effect;IFL;size;Expected Sample Size;relative;Futility Boundary;efficiency;Treatment Effect Size;process;Pocock Boundary;hazard;Log Rank Test;ratio;Relative Efficiency;interim;False Positives;analyses;Effi Cie;Clinical Development Program;Del Power;Cumulative Type;PV Cost;Hazard Ratio;Treatment Effect;Drug Development;True Positives;Expected Log Return;Independent Studies;Global Null Hypothesis;Confirmed Response Rate;Ri Ne