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Predictive Potential of BCS and Pharmacokinetic Parameters on Study Outcome: Analysis of 198 In Vivo Bioequivalence Studies

BACKGROUND AND OBJECTIVES: Understanding predictive potential of parameters to perform early bioequivalence (BE) risk assessment is crucial for good planning and risk mitigation during product development. The objective of the present study was to evaluate predictive potential of various biopharmace...

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Detalles Bibliográficos
Autores principales: Krajcar, Dejan, Grabnar, Iztok, Jereb, Rebeka, Legen, Igor, Opara, Jerneja
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10175306/
https://www.ncbi.nlm.nih.gov/pubmed/36872388
http://dx.doi.org/10.1007/s13318-023-00821-z