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: | Electronic eBook |
| Language: | English |
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New York, NY :
Springer New York : Imprint: Springer,
2010.
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| Online Access: | Full Text via HEAL-Link |
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.
