A comparative study of confidence intervals to assess biosimilarity from analytical data
Author:
Affiliation:
1. Merck & Co. Inc. Research CMC Statistics Kenilworth NJ USA
2. Pfizer Inc. Biosimilar Pharmaceutical Sciences Lake Forest IL USA
3. Pfizer, Inc. Global Biometrics & Data Management Peapack NJ USA
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology,Statistics and Probability
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.1925
Reference16 articles.
1. Development of statistical methods for analytical similarity assessment
2. On assessment of analytical similarity in biosimilar studies;Chow S‐C;Drug Design,2015
3. Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product
4. Statistical Approaches to Assess Biosimilarity from Analytical Data
5. Wald tests for variance-adjusted equivalence assessment with normal endpoints
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