| Title |
Sequential Bioequivalence Approaches for Parallel Designs
|
|---|---|
| Published in |
The AAPS Journal, February 2014
|
| DOI | 10.1208/s12248-014-9571-1 |
| Pubmed ID | |
| Authors |
Anders Fuglsang |
| Abstract |
Regulators in EU, USA and Canada allow the use of two-stage approaches for evaluation of bioequivalence. The purpose of this paper is to evaluate such designs for parallel groups using trial simulations. The methods developed by Diane Potvin and co-workers were adapted to parallel designs. Trials were simulated and evaluated on basis of either equal or unequal variances between treatment groups. Methods B and C of Potvin et al., when adapted for parallel designs, protected well against type I error rate inflation under all of the simulated scenarios. Performance characteristics of the new parallel design methods showed little dependence on the assumption of equality of the test and reference variances. This is the first paper to describe the performance of two-stage approaches for parallel designs used to evaluate bioequivalence. The results may prove useful to sponsors developing formulations where crossover designs for bioequivalence evaluation are undesirable. |
Mendeley readers
The data shown below were compiled from readership statistics for 18 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 18 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 5 | 28% |
| Other | 4 | 22% |
| Researcher | 4 | 22% |
| Student > Ph. D. Student | 2 | 11% |
| Professor > Associate Professor | 1 | 6% |
| Other | 0 | 0% |
| Unknown | 2 | 11% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 4 | 22% |
| Biochemistry, Genetics and Molecular Biology | 4 | 22% |
| Medicine and Dentistry | 3 | 17% |
| Mathematics | 2 | 11% |
| Agricultural and Biological Sciences | 2 | 11% |
| Other | 1 | 6% |
| Unknown | 2 | 11% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 02 June 2014.
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#20,230,558
of 22,756,196 outputs
Outputs from The AAPS Journal
#1,251
of 1,284 outputs
Outputs of similar age
#271,671
of 314,293 outputs
Outputs of similar age from The AAPS Journal
#13
of 14 outputs
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