Buch, Englisch, 248 Seiten, Format (B × H): 163 mm x 241 mm, Gewicht: 1210 g
Buch, Englisch, 248 Seiten, Format (B × H): 163 mm x 241 mm, Gewicht: 1210 g
Reihe: Statistics for Biology and Health
ISBN: 978-0-387-29074-4
Verlag: Springer
This book will answer questions for anyone who has ever visited the pharmacy and wondered how the dosage of their prescription is determined. Dosing information on drug labels is based on discussion between the pharmaceutical manufacturer and the drug regulatory agency, and the label is a summary of results obtained by scientists. This book introduces the drug development process, the design and analysis of clinical trials. Important procedural steps from a pharmaceutical industry perspective are also examined. Although the book is written mainly for statisticians/biostatisticians, it also serves as a useful reference to a variety of professionals working for the pharmaceutical industry and those in a drug regulatory environment. Additionally, statistical and medical professionals in academia may find this book helpful in understanding the drug development process and practical concerns in selecting doses for a new drug.
Zielgruppe
Research
Autoren/Hrsg.
Fachgebiete
- Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
- Interdisziplinäres Wissenschaften Wissenschaften: Forschung und Information Datenanalyse, Datenverarbeitung
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizinische Mathematik & Informatik
- Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Kosmetische Technologie
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie
Weitere Infos & Material
and New Drug Development Process.- Dose Finding Based on Preclinical Studies.- Dose-Finding Studies in Phase I and Estimation of Maximally Tolerated Dose.- Dose-Finding in Oncology—Nonparametric Methods.- Dose Finding in Oncology—Parametric Methods.- Dose Response: Pharmacokinetic–Pharmacodynamic Approach.- General Considerations in Dose–Response Study Designs.- Clinical Trial Simulation—A Case Study Incorporating Efficacy and Tolerability Dose Response.- Analysis of Dose–Response Studies—Emax Model.- Analysis of Dose–Response Studies—Modeling Approaches.- Multiple Comparison Procedures in Dose Response Studies.- Partitioning Tests in Dose–Response Studies with Binary Outcomes.- Analysis of Dose–Response Relationship Based on Categorical Outcomes.- Power and Sample Size for Dose Response Studies.
