Statistical test for evaluation of biosimilarity in variability of follow-On biologics

Journal of Biopharmaceutical Statistics

Volumn 20, Issue 1, 2010, Pages 75-89

  Hsieh, Tsung Cheng ^a,b   Chow, Shein Chung ^a   Liu, Jen Pei ^a,b   Hsiao, Chin Fu ^c   Chi, Eric ^d  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b NATIONAL TAIWAN UNIVERSITY   (Taiwan)

^c NATIONAL HEALTH RESEARCH INSTITUTES   (Taiwan)

^d AMGEN INC   (United States)

Author keywords

Bioequivalence; Biosimilarity; Biosimilars; Probability based criterion

Indexed keywords

BIOLOGICAL PRODUCT;

ARTICLE; BIOTECHNOLOGY; DRUG INDUSTRY; DRUG MANUFACTURE; MATHEMATICAL COMPUTING; PARAMETER; PRIORITY JOURNAL; PROBABILITY; SIMULATION; STATISTICAL ANALYSIS;

ANIMALS; BIOLOGICAL PRODUCTS; HUMANS; MODELS, STATISTICAL; THERAPEUTIC EQUIVALENCY;

EID: 75649092932     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400903367097     Document Type: Article

References (5)

1. Chow, S. C., Liu, J. P. (2008). Design and Analysis of Bioavailability and Bioequivalence Studies. 3rd ed. New York: Chapman Hall/CRC Press, Taylor & Francis.
2. Chow, S. C., Hsieh, E., Chi, E., Yang, J. (2010). A comparison of moment-based and probability-based criteria for assessment of follow-on biologics. Journal of Biopharmaceutical Statistics 20(1):31-45.
3. Food and Drug Administration. (2003). Guidance on Bioavailability and Bioequivalence Studies for Orally Administrated Drug Products-General Considerations. Rockville, MD: Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
4. Fox, A. (2010). Biologics vs. small molecule drugs. Journal of Biopharmaceutical Statistics 20(1):3-9.
5. Tse, S. K., Chang, J. Y., Su, W. L., Chow, S. C., Hsiung, C., Lu, Q. (2006). Statistical quality control process for traditional Chinese medicine. Journal of Biopharmaceutical Statistics 16:861-874.