Eric B. Holmgren: Theory of Drug Development

Cover: 9781138374683 | Theory of Drug Development | Eric B. Holmgren | Taschenbuch | Englisch

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Sprache: Englisch

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Beschreibung

This book focuses on the efficient development of drugs and the quantification of evidence in drug development. It presents a formal quantitative framework for understanding drug development that goes beyond simply describing the properties of the statistics in individual studies. Examining the drug development process from the perspectives of both drug companies and regulatory agencies, the author provides a rationale for underpowered phase 2 trials based on the notion of efficiency and develops a framework for evaluating the strength of evidence generated by clinical trials.

Über den Autor

Eric B. Holmgren is a consultant and statistical scientist. He previously worked at Genentech and Hoechst Roussel Pharmaceuticals. He received a Ph.D. in mathematical statistics from Stanford University.

Inhaltsverzeichnis

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.

Erscheinungsjahr:	2018
Fachbereich:	Wahrscheinlichkeitstheorie
Genre:	Importe , Mathematik
Rubrik:	Naturwissenschaften & Technik
Medium:	Taschenbuch
Inhalt:	Einband - flex.(Paperback)
ISBN-13:	9781138374683
ISBN-10:	1138374687
Sprache:	Englisch
Einband:	Kartoniert / Broschiert
Autor:	Holmgren, Eric B.
Hersteller:	Chapman and Hall/CRC
Verantwortliche Person für die EU:	Libri GmbH, Europaallee 1, D-36244 Bad Hersfeld, gpsr@libri.de
Maße:	234 x 156 x 14 mm
Von/Mit:	Eric B. Holmgren
Erscheinungsdatum:	18.09.2018
Gewicht:	0,406 kg