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In Vitro–In Vivo Correlation (IVIVC) Population Modeling for the In Silico Bioequivalence of a Long-Acting Release Formulation of Progesterone

Health authorities carefully evaluate any change in the batch manufacturing process of a drug before and after regulatory approval. In the absence of an adequate in vitro–in vivo correlation (Level A IVIVC), an in vivo bioequivalence (BE) study is frequently required, increasing the cost and time of...

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Bibliografiske detaljer
Udgivet i:Pharmaceutics
Main Authors: Tosca, Elena M., Rocchetti, Maurizio, Pérez, Elena, Nieto, Conchi, Bettica, Paolo, Moscoso del Prado, Jaime, Magni, Paolo, De Nicolao, Giuseppe
Format: Artigo
Sprog:Inglês
Udgivet: MDPI 2021
Fag:
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC7918143/
https://ncbi.nlm.nih.gov/pubmed/33673306
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3390/pharmaceutics13020255
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