The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics

Statistics in Medicine

Volumn 32, Issue 3, 2013, Pages 406-414

  Hsieh, Tsung Cheng ^a   Chow, Shein Chung ^b   Yang, Lan Yan ^b   Chi, Eric ^c  

^a TZU CHI UNIVERSITY   (Taiwan)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c AMGEN INC   (United States)

Author keywords

Bayesian; Biosimilar index; Biosimilars; Reproducibility probability; Variability

Indexed keywords

BIOSIMILAR AGENT;

ARTICLE; BAYES THEOREM; BIOEQUIVALENCE; BIOSIMILAR INDEX; MONTE CARLO METHOD; PHARMACEUTICS; PROBABILITY; REPRODUCIBILITY PROBABILITY; STATISTICAL ANALYSIS; STATISTICAL MODEL;

ALGORITHMS; BAYES THEOREM; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; DRUG EVALUATION; REPRODUCIBILITY OF RESULTS; UNITED STATES;

EID: 84872387242     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.5570     Document Type: Article

References (10)

1. Fox A. Biologics vs. small molecule drugs. Journal of Biopharmaceutical Statistics 2010; 20(1):3-9.
2. Chow SC, Liu JP. Statistical assessment of biosimilar products. Journal of Biopharmaceutical Statistics 2010; 20:10-30.
3. FDA. Guidance on Statistical Approaches to Establishing Bioequivalence, Center for Drug Evaluation and Research, the US Food and Drug Administration: Rockville, Maryland, USA, 2001.
4. Chow SC, Hsieh E, Chi E, Yang J. A comparison of moment-based and probability-based criteria for assessment of follow-on biologics. Journal of Biopharmaceutical Statistics 2010; 20(1):31-45.
5. Hsieh E, Chow SC, Liu JP, Hsiao CF, Chi E, Yang J. Statistical test for evaluation of biosimilarity in variability of follow-on biologics. Journal of Biopharmaceutical Statistics 2010; 20:74-88.
6. Chow SC, Endrenyi L, Lachenbruch PA, Yang LY, Chi E. Scientific factors for assessing biosimilarity and drug interchangeability of follow-on biologics. Biosimilars 2011; 1:13-26.
7. Shao J, Chow SC. Reproducibility probability in clinical trials. Statistics in Medicine 2002; 21(12):1727-1742.
8. Owen DB. A special case of a non-central t distribution. Biometrika 1965; 52:437-446.
9. Phillips KF. Power of the two one-sided tests procedure in bioequivalence. Journal of Pharmacokinetics and Biopharmaceutics 1990; 18:137-144.
10. Goodman SN. A comment on replication, p-values and evidence. Statistics in Medicine 1992; 11:875-879.