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Registermodel-based BE? [BE/BA News]
Dear all
Please note this interesting and very recent publication by some European regulators (incl members of MWP), which IMHO does not contain solutions yet, but establishes the principle that there is some openness to discuss this topic with EMA:
Manolis, E, García-Arieta, A, Lindahl, A, Kotzagiorgis, E, Limberg, J, Holte, Ø, Paixao, P, Versantvoort, C, Tshinanu, FM, Blake, K, Van Den Heuvel, M. Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective. CPT: pharmacometrics & systems pharmacology. 2023-Jan-11. Link
❝ • EMA does not exclude use of model informed BE, especially in cases when in vivo BE studies cannot be simply conducted in healthy subjects.
❝ • When model-based BE is used, model evaluation should include technical and clinical validation of the model as well as assessment of its applicability.
Please note this interesting and very recent publication by some European regulators (incl members of MWP), which IMHO does not contain solutions yet, but establishes the principle that there is some openness to discuss this topic with EMA:
Manolis, E, García-Arieta, A, Lindahl, A, Kotzagiorgis, E, Limberg, J, Holte, Ø, Paixao, P, Versantvoort, C, Tshinanu, FM, Blake, K, Van Den Heuvel, M. Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective. CPT: pharmacometrics & systems pharmacology. 2023-Jan-11. Link
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Ing. Helmut Schütz