Population PK modelling as an alternative route to bioequivalence

• Príomhchruthaitheoirí: Parmesh Gajjar (Údar), Jake Dickinson (Údar), Harri Dickinson (Údar), Linette Ruston (Údar), Hitesh B Mistry (Údar), Claire Patterson (Údar), Paul A Dickinson (Údar)
• Formáid: LEABHAR
• Foilsithe / Cruthaithe: University of Huddersfield Press, 2022-11-01T00:00:00Z.
• Ábhair: article
• Rochtain ar líne: 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...