Comments on the FDA draft guidance on biosimilar products
- 18 August 2012
- journal article
- research article
- Published by Wiley in Statistics in Medicine
- Vol. 32 (3), 364-369
- https://doi.org/10.1002/sim.5572
Abstract
No abstract availableKeywords
This publication has 5 references indexed in Scilit:
- Statistical assessment of biosimilarity based on relative distance between follow-on biologicsStatistics in Medicine, 2012
- Scientific factors for assessing biosimilarity and drug interchangeability of follow-on biologicsBiosimilars, 2011
- Statistical Test for Evaluation of Biosimilarity in Variability of Follow-On BiologicsJournal of Biopharmaceutical Statistics, 2009
- A Comparison of Moment-Based and Probability-Based Criteria for Assessment of Follow-On BiologicsJournal of Biopharmaceutical Statistics, 2009
- Statistical Assessment of Biosimilar ProductsJournal of Biopharmaceutical Statistics, 2009