Professor Endrenyi’s Legacy: An Evaluation of the Regulatory Requirement “Fixed Effects, Rather Than Random Effects, Should Be Used for All Terms”
Purpose: In the latest revision of the guideline for evaluation of bioequivalence (BE), European regulators introduced the requirement for using subjects as fixed factors in the underlying statistical models, even in replicate and semi-replicate studies. The implication was that estimates of within-...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2021-08-01
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| Series: | Journal of Pharmacy & Pharmaceutical Sciences |
| Online Access: | https://journals.library.ualberta.ca/jpps/index.php/JPPS/article/view/31872 |