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10th Anniversary of a Two-Stage Design in Bioequivalence. Why Has it Still Not Been Implemented?
- Source :
- Pharmaceutical Research; Jul2020, Vol. 37 Issue 7, p1-5, 5p, 1 Diagram, 1 Chart
- Publication Year :
- 2020
-
Abstract
- Purpose: In 2010 the European Medicines Agency allowed a two-stage design in bioequivalence studies. However, in the public domain there are mainly articles describing the theoretical and statistical base for the application of the two-stage design. One of the reasons seems to be the lack of practical guidance for the Sponsors on when and how the two-stage design can be beneficial in bioequivalence studies. Methods: Different variants with positive and negative outcomes have been evaluated, including a pivotal study, pilot + pivotal study and two-stage study. The scientific perspective on the two-stage bioequivalence study has been confronted with the industrial one. Results: Key information needed to conduct a bioequivalence study – such as in vitro data and pharmacokinetics – have been listed and organized into a decision scheme. Advantages and disadvantages of the two-stage design have been summarized. Conclusion: The use of the two-stage design in bioequivalence studies seems to be a beneficial alternative to the 2 × 2 crossover study. Basic information on the properties of the active substance and the characteristics of the drug form are needed to make an initial decision to carry out the two-stage study. [ABSTRACT FROM AUTHOR]
- Subjects :
- PHARMACOKINETICS
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ANNIVERSARIES
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Details
- Language :
- English
- ISSN :
- 07248741
- Volume :
- 37
- Issue :
- 7
- Database :
- Complementary Index
- Journal :
- Pharmaceutical Research
- Publication Type :
- Academic Journal
- Accession number :
- 144730610
- Full Text :
- https://doi.org/10.1007/s11095-020-02871-3