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

• Main Authors: Elena M. Tosca (Author), Maurizio Rocchetti (Author), Elena Pérez (Author), Conchi Nieto (Author), Paolo Bettica (Author), Jaime Moscoso del Prado (Author), Paolo Magni (Author), Giuseppe De Nicolao (Author)
• Format: Book
• Published: MDPI AG, 2021-02-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...