Statistical methods for assessing interchangeability of biosimilars

Statistics in Medicine

Volumn 32, Issue 3, 2013, Pages 442-448

  Chow, Shein Chung ^a   Yang, Lan Yan ^a,b   Starr, Aijing ^c   Chiu, Shih Ting ^d  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Change Gung University   (Taiwan)

^c NORTH CAROLINA STATE UNIVERSITY   (United States)

^d NATIONAL TAIWAN UNIVERSITY   (Taiwan)

Author keywords

Alternating; Biosimilars; Follow on biologics; Interchangeability; Switching

Indexed keywords

BIOLOGICAL PRODUCT; BIOSIMILAR AGENT;

ANALYTIC METHOD; ARTICLE; BIOEQUIVALENCE; CHEMICAL STRUCTURE; DRUG HALF LIFE; DRUG MANUFACTURE; DRUG SUBSTITUTION; ENVIRONMENTAL FACTOR; ENVIRONMENTAL TEMPERATURE; FOOD AND DRUG ADMINISTRATION; ILLUMINATION; IMMUNOGENICITY; MATHEMATICAL ANALYSIS; METHODOLOGY; PROBABILITY; QUALITY CONTROL; QUANTITATIVE ANALYSIS; REPRODUCIBILITY; STATISTICAL ANALYSIS; UNITED STATES;

ALGORITHMS; BIOSIMILAR PHARMACEUTICALS; CROSS-OVER STUDIES; DRUG SUBSTITUTION; HUMANS; UNITED STATES;

EID: 84872383751     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.5566     Document Type: Article

References (17)

1. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of Pharmacokinetics and Biopharmaceutics 1987; 15:657-680.
2. EMEA. Note for Guidance on the Investigation of Bioavailability and Bioequivalence, The European Medicines Agency Evaluation of Medicines for Human Use. EMEA/EWP/QWP/1401/98: London, United Kingdom, 2001.
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. FDA. Guidance on Bioavailability and Bioequivalence Studies for Orally Administrated Drug Products - General Considerations, Center for Drug Evaluation and Research, the US Food and Drug Administration: Rockville, Maryland, USA, 2003.
5. FDA. Guidance on Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action, Center for Drug Evaluation and Research, the US Food and Drug Administration: Rockville, Maryland, USA, 2003.
6. WHO. World Health Organization Draft Revision on Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability: Geneva, Switzerland, 2005.
7. Chow SC, Liu JP. Design and Analysis of Bioavailability and Bioequivalence Studies, 3rd ed. Taylor & Francis: New York, New York, 2008.
8. Shao J, Chow SC. Reproducibility probability in clinical trials. Statistics in Medicine 2002; 21:1727-1742.
9. 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.
10. Chow SC. Quantitative evaluation of bioequivalence/biosimilarity. Journal of Bioequivalence and Bioavailability 2011; S1. DOI: 10.4172/jbb.S1-002.
11. David H, Nagaraja H. Order Statistics, John Wiley & Sons: New York, 2003.
12. David H. Order Statistics, Wiley: New York, 1981.
13. Gumbel EJ. The maxima of the mean largest value and of the range. Annals of Mathematical Statistics 1954; 25:76-84.
14. Hartley HO, David HA. Universal bounds for mean range and extreme observation. Annals of Mathematical Statistics 1954; 25:85-99.
15. Arnold B, Groeneveld R. Bound on expectations of linear systematic statistics based on dependent samples. The Annals of Statistics 1979; 7:220-223.
16. Papadatos N. Maximum variance of order statistics. Annals of the Institute of Statistical Mathematics 1995; 47:185-193.
17. Casella G, Berger R. Statistical Inference, 2nded. Duxbury: Pacific Grove, CA, 2002.