Mechanistic modeling of ophthalmic, nasal, injectable, and implant generic drug products: A workshop summary report

• Main Authors: Ming‐Liang Tan (Author), Sajeev Chandran (Author), Rebeka Jereb (Author), Khondoker Alam (Author), Robert Bies (Author), Darby Kozak (Author), Ross Walenga (Author), Maxime Le Merdy (Author), Andrew Babiskin (Author)
• Format: Book
• Published: Wiley, 2023-05-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract For approval, a proposed generic drug product must demonstrate it is bioequivalent (BE) to the reference listed drug product. For locally acting drug products, conventional BE approaches may not be feasible because measurements in local tissues at the sites of action are often impractical,...