Innovative Methods for Rare Disease Drug Development (Paperback)

Reviews critical issues (e.g., endpoint/margin selection, sample size requirement and complex innovative design). Provides better understanding of statistical concepts and methods which may be used in regulatory review and approval. Clarifies controversial statistical issues in regulatory review and approval. Makes recommendations to accurately and reliably evaluate rare diseases regulatory submissions. Proposes innovative study designs and statistical methods for rare diseases drug development including n-of-1 trial design, adaptive trial design, and master protocols such as platform trials. Provides insight regarding current regulatory guidance on rare diseases drug development such as gene therapy.

General

Imprint:	Crc Press
Country of origin:	United Kingdom
Series:	Chapman & Hall/CRC Biostatistics Series
Release date:	May 2022
First published:	2021
Authors:	Shein-Chung Chow
Dimensions:	234 x 156 x 22mm (L x W x T)
Format:	Paperback
Pages:	306
ISBN-13:	978-0-367-50290-4
Categories:	Books > Science & Mathematics > Mathematics > Probability & statistics Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
LSN:	0-367-50290-9
Barcode:	9780367502904

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