Holmgren Theory of Drug Development

Erscheinungsjahr 2013
ISBN: 978-1-4665-0747-0
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 261 Seiten

Reihe: Chapman & Hall/CRC Biostatistics Series

During drug development, pharmaceutical companies test new molecules and assemble the necessary evidence required by regulatory agencies to show that a drug is safe and effective. This book presents a quantitative framework for evaluating the efficiency of the drug development process as well as the quality of the resulting evidence supporting clinical efficacy. Using this framework, the author formally evaluates a variety of issues that arise in drug development, from surrogate variables, targeted therapies, and interim analysis to seamless phase II/III designs.

Autoren/Hrsg.

Holmgren, Eric B.

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Mathematik | Informatik Mathematik Stochastik

Inhaltsverzeichnis

Clinical Development Phases I-III. Choosing Drugs to Develop. Phase II/III Strategy. Phase III without a Preceding Phase II. Single-Arm Phase II Trial. Phase II Trials Based on Surrogates. The Dose Selection/Subgroup Problem: Phase II as a Pilot Trial. Multistage Screening. Regulatory Assessment of Evidence. Adaptive Phase II/III Designs. The Size of the Phase II Trial. Appendix.