Roychoudhury / Lahiri Statistical Approaches in Oncology Clinical Development

Current Paradigm and Methodological Advancement
1. Auflage 2018
ISBN: 978-1-4987-7270-9
Verlag: CRC Press
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 236 Seiten

Reihe: Chapman & Hall/CRC Biostatistics Series

Oncology is a rapidly developing area in medical science. A significant investment in terms of costs, resources and time is required for oncology drug development. Understanding of the challenges at all stages is vital for a successful drug launching. The purpose of this book is to provide an overview and practical solutions to some of these challenges which are commonly observed during setting up, conducting and reporting of oncology studies. This book will cover a wide variety of topics related to common challenges in cancer clinical trials across different stages of drug development.

Autoren/Hrsg.

Roychoudhury, Satrajiit

Roychoudhury, Satrajit

Lahiri, Soumi

Fachgebiete

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

Inhaltsverzeichnis

Introduction. Phase I Oncology Trials. Exposure Response Analysis. Phase II Trials in Oncology. Selected Hurdles in Phase III Confirmatory Setting. Safety analysis. Quality of Life Data Analysis. Design and Analysis of Biosimilar Trials in Oncology. Regulatory Challenges.