Analytical Similarity Assessment in Biosimilar Product Development

1st Edition

Shein-Chung Chow

Chapman and Hall/CRC
Published August 1, 2018
Reference - 340 Pages
ISBN 9781138307339 - CAT# K35785

For Instructors Request Inspection Copy

USD$169.95

Add to Wish List
FREE Standard Shipping!

Features

Will be the first book focusing on analytical similarity assessment in biosimilar product development

Emphasizes the concept of variability associated with estimated equivalence acceptance criterion (EAC) for providing a more accurate and reliable assessment of the conducted analytical studies

Introduces FDA’s current thinking on the controversial issues

Provides a comprehensive review and comparison of various statistical methods

Summary

This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment.

Instructors

We provide complimentary e-inspection copies of primary textbooks to instructors considering our books for course adoption.

Request an
e-inspection copy

Share this Title