Population PK modelling as an alternative route to bioequivalence

• Main Authors: Parmesh Gajjar (Author), Jake Dickinson (Author), Harri Dickinson (Author), Linette Ruston (Author), Hitesh B Mistry (Author), Claire Patterson (Author), Paul A Dickinson (Author)
• Format: Book
• Published: University of Huddersfield Press, 2022-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Demonstrating bioequivalence (BE) is important for the development of lower-cost generic products, and also for approving post-submission manufacturing changes. However, for many complex parenteral products, BE demonstration can be very challenging. For example, long-acting injectable products are e...