E-Book, Englisch, 705 Seiten, eBook
Reihe: Statistics for Biology and Health
ISBN: 978-3-319-23558-5
Verlag: Springer International Publishing
Format: PDF
Kopierschutz: Wasserzeichen (»Systemvoraussetzungen)
Zielgruppe
Research
Weitere Infos & Material
Introduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries.- Regulatory Nonclinical Statistics.- How to be a good nonclinical statistician.- Statistical Methods for Drug Discovery.- High-throughput Screening Data Analysis.- Quantitative-Structure Activity Relationship Modeling and Cheminformatics.- GWAS for Drug Discovery.- Statistical applications in Design and Analysis of In-Vitro Safety Screening Assays.- Nonclinical safety assessment: an introduction for statisticians.- General Toxicology, Safety Pharmacology, Reproductive Toxicology and Juvenile Toxicology Studies.- Clinical Assays for Biological Macromolecules.- Recent Research Projects by FDA's Pharmacology and Toxicology Statistics Team.- Design and evaluation of drug combination studies.- Biomarkers.- Overview of Drug Development and Statistical Tools for Manufacturing and Testing.- Assay Validation.- Lifecycle Approach to Bioassay.- Quality by Design: Building Quality into Products and Processes.- Process Validation.- Acceptance Sampling.- Process Capability and Statistical Process Control.- Statistical Considerations for Stability and the Estimation of Shelf Life.- In Vitro Dissolution Testing: Statistical Approaches and Issues.- Assessing Content Uniformity.- Chemometrics and Predictive Modelling.- Statistical Methods for Comparability Studies.