A comparison of group sequential and fixed sample size designs for bioequivalence trials with highly variable drugs
A drug is defined as highly variable if its intra-individual coefficient of variation (CV) is greater than or equal to 30%. In such a case, bioequivalence may be assessed by means of methods that take the (high) variability into account. The Scaled Average Bioequivalence (SABE) approach is such a pr...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
23 January 2018
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| In: |
European journal of clinical pharmacology
Year: 2018, Volume: 74, Issue: 5, Pages: 549-559 |
| ISSN: | 1432-1041 |
| DOI: | 10.1007/s00228-018-2415-7 |
| Online Access: | Resolving-System, Volltext: https://doi.org/10.1007/s00228-018-2415-7 Verlag: https://link.springer.com/article/10.1007%2Fs00228-018-2415-7 
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| Author Notes: | Sophie I. E. Knahl, Benjamin Lang, Frank Fleischer, Meinhard Kieser |
| Summary: | A drug is defined as highly variable if its intra-individual coefficient of variation (CV) is greater than or equal to 30%. In such a case, bioequivalence may be assessed by means of methods that take the (high) variability into account. The Scaled Average Bioequivalence (SABE) approach is such a procedure and represents the recommendations of FDA. The aim of this investigation is to compare the performance characteristics of classical group sequential designs (GSD) and fixed design settings for three-period crossover bioequivalence studies with highly variable drugs, where the SABE procedure is utilized. |
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| Item Description: | Gesehen am 20.11.2019 |
| Physical Description: | Online Resource |
| ISSN: | 1432-1041 |
| DOI: | 10.1007/s00228-018-2415-7 |