Statistical considerations in bioequivalence trials
Publication
, Journal Article
Chow, SC; Liu, JP
Published in: Communications in Statistics - Theory and Methods
January 1, 1994
We discuss the statistical issues in evaluation of bioequivalence addressed by the FDA Bioequivalence Hearing (1986) and Guidance on Statistical Procedures for Bioequivalence Studies released by the Division of Bioequivalence, Office of Generic Drugs of FDA (1992). They are logarithmic transformation of pharmacokinetic data, sequence effect, and outlying data. We also compare the additive model with the multiplicative model, examine the relationship between intrasubject variability and interchangeability, describe the concept of population versus individual bioequivalence, and investigate the distributions of AUC and Cmax. © 1994, Taylor & Francis Group, LLC. All rights reserved.
Duke Scholars
Published In
Communications in Statistics - Theory and Methods
DOI
EISSN
1532-415X
ISSN
0361-0926
Publication Date
January 1, 1994
Volume
23
Issue
2
Start / End Page
325 / 339
Related Subject Headings
- Statistics & Probability
- 4905 Statistics
- 0199 Other Mathematical Sciences
- 0104 Statistics
Citation
APA
Chicago
ICMJE
MLA
NLM
Chow, S. C., & Liu, J. P. (1994). Statistical considerations in bioequivalence trials. Communications in Statistics - Theory and Methods, 23(2), 325–339. https://doi.org/10.1080/03610929408831258
Chow, S. C., and J. P. Liu. “Statistical considerations in bioequivalence trials.” Communications in Statistics - Theory and Methods 23, no. 2 (January 1, 1994): 325–39. https://doi.org/10.1080/03610929408831258.
Chow SC, Liu JP. Statistical considerations in bioequivalence trials. Communications in Statistics - Theory and Methods. 1994 Jan 1;23(2):325–39.
Chow, S. C., and J. P. Liu. “Statistical considerations in bioequivalence trials.” Communications in Statistics - Theory and Methods, vol. 23, no. 2, Jan. 1994, pp. 325–39. Scopus, doi:10.1080/03610929408831258.
Chow SC, Liu JP. Statistical considerations in bioequivalence trials. Communications in Statistics - Theory and Methods. 1994 Jan 1;23(2):325–339.
Published In
Communications in Statistics - Theory and Methods
DOI
EISSN
1532-415X
ISSN
0361-0926
Publication Date
January 1, 1994
Volume
23
Issue
2
Start / End Page
325 / 339
Related Subject Headings
- Statistics & Probability
- 4905 Statistics
- 0199 Other Mathematical Sciences
- 0104 Statistics