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Statistical methods for assessing interchangeability of biosimilars.

Publication ,  Journal Article
Chow, S-C; Yang, L-Y; Starr, A; Chiu, S-T
Published in: Stat Med
February 10, 2013

Unlike traditional small molecule (chemical) drug products, the development of biologic products is very different and variable with respect to the manufacturing process and environmental factors such as light and temperature. The complexity and heterogeneity of the molecular structure, complicated manufacturing process, different analytical methods, and possibility of severe immunogenicity reactions make quantitative evaluation of follow-on biologics a great challenge to both scientific community and regulatory agencies. In this article, we propose a general approach for development of a biosimilarity index based on the concept of reproducibility probability for quantitative evaluation of biosimilarity and interchangeability. The proposed method is robust regardless the biosimilarity criteria used and/or study design employed.

Duke Scholars

Published In

Stat Med

DOI

EISSN

1097-0258

Publication Date

February 10, 2013

Volume

32

Issue

3

Start / End Page

442 / 448

Location

England

Related Subject Headings

  • United States
  • Statistics & Probability
  • Humans
  • Drug Substitution
  • Cross-Over Studies
  • Biosimilar Pharmaceuticals
  • Algorithms
  • 4905 Statistics
  • 4202 Epidemiology
  • 1117 Public Health and Health Services
 

Citation

APA
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ICMJE
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Chow, S.-C., Yang, L.-Y., Starr, A., & Chiu, S.-T. (2013). Statistical methods for assessing interchangeability of biosimilars. Stat Med, 32(3), 442–448. https://doi.org/10.1002/sim.5566
Chow, Shein-Chung, Lan-Yan Yang, Aijing Starr, and Shih-Ting Chiu. “Statistical methods for assessing interchangeability of biosimilars.Stat Med 32, no. 3 (February 10, 2013): 442–48. https://doi.org/10.1002/sim.5566.
Chow S-C, Yang L-Y, Starr A, Chiu S-T. Statistical methods for assessing interchangeability of biosimilars. Stat Med. 2013 Feb 10;32(3):442–8.
Chow, Shein-Chung, et al. “Statistical methods for assessing interchangeability of biosimilars.Stat Med, vol. 32, no. 3, Feb. 2013, pp. 442–48. Pubmed, doi:10.1002/sim.5566.
Chow S-C, Yang L-Y, Starr A, Chiu S-T. Statistical methods for assessing interchangeability of biosimilars. Stat Med. 2013 Feb 10;32(3):442–448.
Journal cover image

Published In

Stat Med

DOI

EISSN

1097-0258

Publication Date

February 10, 2013

Volume

32

Issue

3

Start / End Page

442 / 448

Location

England

Related Subject Headings

  • United States
  • Statistics & Probability
  • Humans
  • Drug Substitution
  • Cross-Over Studies
  • Biosimilar Pharmaceuticals
  • Algorithms
  • 4905 Statistics
  • 4202 Epidemiology
  • 1117 Public Health and Health Services