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Global New Drug Development

- An Introduction

Om Global New Drug Development

The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market. This book offers an introduction to the field of drug development with a clear overview of the different processes that lead to a successful new medicine and of the regulatory pathways that are used to launch a new drug that are both safe and efficacious. "This is the most comprehensive and detailed book on drug development I have ever read and I feel that it is likely to become a staple of drug development courses, such as those taught at Masters Level in my own University.... I think in the light of increasing integration of company and academic approaches to drug development both sides can read this book.. (and, therefore)... this book could not be more timely. " Professor Mike Coleman, University of Aston., UK ( from his review of the final manuscript)

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  • Språk:
  • Engelska
  • ISBN:
  • 9781118414880
  • Format:
  • Inbunden
  • Sidor:
  • 424
  • Utgiven:
  • 19. september 2014
  • Mått:
  • 170x250x25 mm.
  • Vikt:
  • 904 g.
Leveranstid: 2-4 veckor
Förväntad leverans: 27. december 2024
Förlängd ångerrätt till 31. januari 2025

Beskrivning av Global New Drug Development

The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market.
This book offers an introduction to the field of drug development with a clear overview of the different processes that lead to a successful new medicine and of the regulatory pathways that are used to launch a new drug that are both safe and efficacious.
"This is the most comprehensive and detailed book on drug development I have ever read and I feel that it is likely to become a staple of drug development courses, such as those taught at Masters Level in my own University.... I think in the light of increasing integration of company and academic approaches to drug development both sides can read this book.. (and, therefore)... this book could not be more timely. "
Professor Mike Coleman, University of Aston., UK ( from his review of the final manuscript)

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