Advanced Statistics in Regulatory Critical Clinical Initiatives by Zhang, Wei

Advanced Statistics in Regulatory Critical Clinical Initiatives (Hardcover) (ISBN-13: 9780367561789)

Vendor: Wei Zhang
Product type: Books
Format: Hardcover
$190.00
$190.00
$190.00
Subtotal: $190.00
Advanced Statistics in Regulatory Critical Clinical Initiatives by Zhang, Wei

Advanced Statistics in Regulatory Critical Clinical Initiatives

$190.00
Advanced Statistics in Regulatory Critical Clinical Initiatives by Zhang, Wei

Advanced Statistics in Regulatory Critical Clinical Initiatives

$190.00
Format: Hardcover
Description
Description
x

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.


    • Author: Wei Zhang
    ISBN-10: 0367561786
    ISBN-13: 9780367561789
    Publisher: CRC Press
    Language: English
    Published: 05/26/2022
    Pages: 307
    Format: Hardcover
    Weight: 1.69lbs
    Size: 10.00h x 7.00w x 0.75d
By Wei Zhang
By Wei Zhang
x

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.

Recently Viewed Products