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...

Πλήρης περιγραφή

Λεπτομέρειες βιβλιογραφικής εγγραφής
Κύριος συγγραφέας: Turner, J. Rick (Συγγραφέας)
Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
Γλώσσα:English
Έκδοση: New York, NY : Springer New York : Imprint: Springer, 2010.
Θέματα:
Διαθέσιμο Online:Full Text via HEAL-Link
Πίνακας περιεχομένων:
  • 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.