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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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Turner, J. Rick (Autor)
Autor Corporativo: SpringerLink (Online service)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: New York, NY : Springer New York : Imprint: Springer, 2010.
Edición:2nd ed. 2010.
Temas:
Pharmaceutical chemistry.
Pharmaceutics.
Acceso en línea:Texto Completo
Tabla de Contenidos:
  • 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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