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Advanced Statistics in Regulatory Critical Clinical Initiatives

Engelsk Paperback
SPAR
kr 81

Advanced Statistics in Regulatory Critical Clinical Initiatives

Engelsk Paperback

Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields.

Key Features:

  • Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development.
  • Makes recommendations to evaluate submissions accurately and reliably.
  • Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development.
  • Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.
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Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields.

Key Features:

  • Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development.
  • Makes recommendations to evaluate submissions accurately and reliably.
  • Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development.
  • Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.
Produktdetaljer
Sprog: Engelsk
Sider: 307
ISBN-13: 9780367609955
Indbinding: Paperback
Udgave:
ISBN-10: 0367609959
Kategori: Kliniske forsøg
Udg. Dato: 27 maj 2024
Længde: 0mm
Bredde: 254mm
Højde: 178mm
Forlag: Taylor & Francis Ltd
Oplagsdato: 27 maj 2024
Forfatter(e):
Forfatter(e)


Kategori Kliniske forsøg


Sprog Engelsk


Indbinding Paperback


Sider 307


Udgave


Længde 0mm


Bredde 254mm


Højde 178mm


Udg. Dato 27 maj 2024


Oplagsdato 27 maj 2024

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