Pediatric drug development concepts and applications /

Gespeichert in:
Bibliographische Detailangaben
Körperschaft: ebrary, Inc
Weitere Verfasser: Mulberg, Andrew E.
Format: Elektronisch E-Book
Sprache:Englisch
Veröffentlicht: Hoboken, N.J. : Wiley, 2013.
Ausgabe:2nd ed.
Schlagworte:
Online-Zugang:An electronic book accessible through the World Wide Web; click to view
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Inhaltsangabe:
  • pt. I. Past, present, and future of pediatric drug development
  • pt. II. Ethical underpinnings
  • pt. III. Regulatory guidelines for pediatric drug development
  • pt. IV. Preclinical safety assessment
  • pt. V. Pharmacological principles in pediatric drug development
  • pt. VI. Clinical trial operations
  • pt. VII. Clinical trial operations and good clinical trials
  • pt. VIII. Clinical efficacy and safety endpoints
  • pt. IX. Formulation, chemistry and manufacturing controls.