Intelligent drug development : trials and errors in clinical research /

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Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringe...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Tansey, Michael (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Oxford ; New York : Oxford University Press, [2014]
Temas:
Drugs > Testing > Methodology.
Drug development > Management.
Clinical trials > Ethics.
Clinical trials > Methods.
Drug approval > Methods.
Medical protocols.
Drug Approval > methods
Clinical Protocols
Clinical Trials as Topic > ethics
Clinical Trials as Topic > methods
Médicaments > Essais cliniques > Méthodologie.
Médicaments > Développement > Gestion.
Études cliniques > Morale.
Protocoles médicaux.
MEDICAL > Pharmacology.
Drugs > Testing > Methodology
Medical protocols
Clinical trials
Drug approval
Methods (Music)
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Aiming for excellence
  • The target product profile and its uses
  • Planning the individual clinical trial
  • Distilling the essence of the protocol: the protocol synopsis
  • Redistillation: eliminating impurities by carrying out protocol feasibility
  • The optimal blend: the approved synopsis and the final protocol
  • Of chickens and eggs: the sponsors' dilemma
  • Clinician or clinical trialist: the physicians' dilemma
  • What about the customer? the patients' dilemma
  • About time: making meetings matter
  • The brain-scrambling, fit-inducing, mind-numbing technicolor laser show.

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