Design and Analysis of Follow-on Biologics
To Be Published August 2nd 2013 by Chapman and Hall/CRC – 424 pages
This is the first book entirely devoted to the design and analysis for assessment of biosimilarity and drug interchangeability of biosimilars, and test for comparability in manufacturing processes of biologic products. It covers all of the statistical issues that may occur in biosimilar studies under various study designs at various stages of research and development of biologic products.
Introduction. Bioequivalence Experience for Drug Products. Regulatory Requirement for Assessing Follow-on Biologics. Criteria for Similarity. Statistical Methods for Assessing Average Biosimilarity. General Approach for Assessing Biosimilarity. Non-Inferiority versus Equivalence. Assessment of Biosimilarity in Variability. Impact of Variability on Biosimilarity Limits for Assessing Follow-on Biologics. Drug Interchangeability. CMC Requirements for Biological Products. Test for Comparability in Manufacturing Process. Stability Analysis. Current Issues in Biosimilar Studies. References. Index.