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Nonclinical Statistics for Pharmaceutical and Biotechnology Industries
This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. Thi...
| Clasificación: | Libro Electrónico |
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| Autor Corporativo: | |
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Cham :
Springer International Publishing : Imprint: Springer,
2016.
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| Edición: | 1st ed. 2016. |
| Colección: | Statistics for Biology and Health,
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| Temas: | |
| Acceso en línea: | Texto Completo |
Tabla de Contenidos:
- 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.