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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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Bibliographic Details
Main Author: Turner, J. Rick. (Author, http://id.loc.gov/vocabulary/relators/aut)
Corporate Author: SpringerLink (Online service)
Format: Electronic eBook
Language:English
Published: New York, NY : Springer New York : Imprint: Springer, 2010.
Edition:2nd ed. 2010.
Subjects:
Pharmaceutical technology.
Pharmaceutical Sciences/Technology.
Online Access:https://doi.org/10.1007/978-1-4419-6418-2
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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.

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