Development of Mechanistic In Vitro-In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables

• Main Authors: Daniela Amaral Silva (Author), Maxime Le Merdy (Author), Khondoker Dedarul Alam (Author), Yan Wang (Author), Quanying Bao (Author), Nilesh Malavia (Author), Diane Burgess (Author), Viera Lukacova (Author)
• Format: Book
• Published: MDPI AG, 2024-04-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Long-acting injectable (LAI) formulations provide sustained drug release over an extended period ranging from weeks to several months to improve efficacy, safety, and compliance. Nevertheless, many challenges arise in the development and regulatory assessment of LAI drug products due to a limited un...