| Titre : | Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting |
| Auteurs : | Qi Jiang, Auteur ; Amy Xia H., Auteur |
| Type de document : | Monographie imprimée |
| Mention d'édition : | 1st edition |
| Editeur : | CRC Press Editeur, 2020 |
| ISBN/ISSN/EAN : | 978-0-367-57600-4 |
| Format : | 1VOL.(382.p) / ill.couv.ill.en coul / 23.5cm |
| Langues: | Anglais |
| Langues originales: | Anglais |
| Résumé : |
Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment.The book’s three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. |
| Sommaire : |
Study Design. Safety Monitoring. Evaluation/Analysis. Index. |
| Type de document : | Livres |
Disponibilité (2)
| Cote | Support | Localisation | Statut |
|---|---|---|---|
| CH/690 | Livre | bibliothèque sciences exactes | Empruntable |
| CH/690 | Livre | bibliothèque sciences exactes | Empruntable |
