Advanced Statistics in Regulatory Critical Clinical Initiatives - Brossura

 
9780367609955: Advanced Statistics in Regulatory Critical Clinical Initiatives
Brossura
ISBN 10: 0367609959 ISBN 13: 9780367609955
Casa editrice: Chapman and Hall/CRC, 2024

Sinossi

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.

Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.

Informazioni sull?autore

Wei Zhang is the Vice President, Head of Biometrics at AffaMed Therapeutics, New York.

Fangrong Yan is a Professor of Biostatistics in the School of Science, and Director of Biostatistics and Computational Pharmacy Research Center at China Pharmaceutical University (CPU).

Feng Chen is a Professor of Biostatistics in School of Public Health, Nanjing Medical University (NJMU).

Shein-Chung Chow is currently a Professor at the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham.

Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.

Editore
Chapman and Hall/CRC
Data di pubblicazione
2024
Lingua
Inglese
ISBN 10 
0367609959
ISBN 13 
9780367609955
Rilegatura
Copertina flessibile
Numero edizione
1
Numero di pagine
318
Redattore
Zhang Wei, Yan Fangrong, Chen Feng, Chow Shein-Chung
Contatto del produttore
non disponibile
Persona responsabile
non disponibile

Altre edizioni note dello stesso titolo

9780367561789: Advanced Statistics in Regulatory Critical Clinical Initiatives

Edizione in evidenza

ISBN 10:  0367561786 ISBN 13:  9780367561789
Casa editrice: Chapman and Hall/CRC, 2022
Rilegato