Pediatric drug development : concepts and applications /

Mostrar otras versiones (1)

Pediatric Drug Development, Second Edition, encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other no...

Descripción completa

Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Mulberg, Andrew E. (Editor ), Murphy, M. Dianne (Editor ), Dunne, Julia, 1954- (Editor ), Mathis, Lisa L. (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Chichester, West Sussex, UK : Wiley Blackwell, 2013.
Edición:Second edition.
Temas:
Pediatric pharmacology.
Drug development.
Children.
Age factors in disease.
Child
Drug Evaluation > methods
Age Factors
Clinical Trials as Topic > standards
Drug Evaluation > ethics
Drug Evaluation > standards
Pharmacologie pédiatrique.
Médicaments > Développement.
Enfants.
Maladies > Facteurs liés à l'âge.
children (people by age group)
MEDICAL > Drug Guides.
MEDICAL > Nursing > Pharmacology.
MEDICAL > Pharmacology.
MEDICAL > Pharmacy.
Children
Age factors in disease
Drug development
Pediatric pharmacology
Internet Resources.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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.

Ejemplares similares