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Clinical trials handbook /
Best practices for conducting effective and safe clinical trials. Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, p...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken, NJ :
Wiley,
©2009.
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| Colección: | Pharmaceutical Development Series.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Clinical Trials Handbook; Contents; Preface; Contributors; 1 Introduction to Clinical Trials; 2 Regulatory Requirements for Investigational New Drug; 3 Preclinical Assessment of Safety in Human Subjects; 4 Predicting Human Adverse Drug Reactions from Nonclinical Safety Studies; 5.1 History of Clinical Trial Development and the Pharmaceutical Industry; 5.2 Adaptive Research; 6 Organization and Planning; 7 Process of Data Management; 8 Clinical Trials Data Management; 9.1 Clinical Trials and the Food and Drug Administration; 9.2 Phase I Clinical Trials; 9.3 Phase II Clinical Trials.
- 9.4 Designing and Conducting Phase III Studies9.5 Phase IV: Postmarketing Trials; 9.6 Phase IV and Postmarketing Clinical Trials; 9.7 Regulatory Approval; 9.8 New Paradigm for Analyzing Adverse Drug Events; 10.1 Clinical Trials in Interventional Cardiology: Focus on XIENCE Drug-Eluting Stent; 10.2 Clinical Trials Involving Oral Diseases; 10.3 Dermatology Clinical Trials; 10.4 Emergency Clinical Trials; 10.5 Gastroenterology; 10.6 G.