New Drug Development An Introduction to Clinical Trials: Second Edition
New Drug Development, 2nd Edition, is a reader-friendly introduction to clinical trials that is written specifically for entry-level professionals in the pharmaceutical, biopharmaceutical, and contract research organization (CRO) industries. It is also excellent reading for seasoned clinical researc...
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| Format: | eBook |
| Language: | English |
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New York, NY
Springer New York
2010, 2010
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| Edition: | 2nd ed. 2010 |
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| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
Table of Contents:
- New Drug Development
- The Regulatory Environment
- Drug Discovery
- Nonclinical Research
- Designing Clinical Trials
- Conducting Clinical Trials I: Experimental Methodology
- Conducting Clinical Trials II: Operational Execution
- Statistical Analysis
- Statistical Significance
- Clinical Significance
- Sample Size Estimation
- General Safety Assessments
- Efficacy Assessment
- Cardiac and Cardiovascular Safety Assessments
- Manufacturing Small Molecule Drugs and Biologicals
- Postmarketing Surveillance
- Main Themes and Concluding Comments