On sample size calculation in bioequivalence trials.
Publication
, Journal Article
Chow, SC; Wang, H
Published in: J Pharmacokinet Pharmacodyn
April 2001
Sample size calculation plays an important role in bioequivalence trials. In practice, a bioequivalence study is usually conducted under a crossover design or a parallel design with raw data or log-transformed data. In this paper, we discuss the differences in sample size calculation between a crossover design and a parallel design with raw data or log-transformed data. Formulas for sample size calculation under a crossover design and a parallel design with raw data or log-transformed data are derived. A brief discussion for the relationship among these formulas is given.
Duke Scholars
Published In
J Pharmacokinet Pharmacodyn
DOI
ISSN
1567-567X
Publication Date
April 2001
Volume
28
Issue
2
Start / End Page
155 / 169
Location
United States
Related Subject Headings
- Therapeutic Equivalency
- Sample Size
- Pharmacology & Pharmacy
- Humans
- Cross-Over Studies
- Clinical Trials as Topic
- 3214 Pharmacology and pharmaceutical sciences
- 1115 Pharmacology and Pharmaceutical Sciences
Citation
APA
Chicago
ICMJE
MLA
NLM
Chow, S. C., & Wang, H. (2001). On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn, 28(2), 155–169. https://doi.org/10.1023/a:1011503032353
Chow, S. C., and H. Wang. “On sample size calculation in bioequivalence trials.” J Pharmacokinet Pharmacodyn 28, no. 2 (April 2001): 155–69. https://doi.org/10.1023/a:1011503032353.
Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155–69.
Chow, S. C., and H. Wang. “On sample size calculation in bioequivalence trials.” J Pharmacokinet Pharmacodyn, vol. 28, no. 2, Apr. 2001, pp. 155–69. Pubmed, doi:10.1023/a:1011503032353.
Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155–169.
Published In
J Pharmacokinet Pharmacodyn
DOI
ISSN
1567-567X
Publication Date
April 2001
Volume
28
Issue
2
Start / End Page
155 / 169
Location
United States
Related Subject Headings
- Therapeutic Equivalency
- Sample Size
- Pharmacology & Pharmacy
- Humans
- Cross-Over Studies
- Clinical Trials as Topic
- 3214 Pharmacology and pharmaceutical sciences
- 1115 Pharmacology and Pharmaceutical Sciences