Toward the practical implementation of eye-related bioavailability prediction models.
The development and registration of reformulated ophthalmic products (OPs) requires eye-related bioavailability (BA) assessments. Common BA algorithms associated with other routes of application, such as the oral route, cannot be easily applied to eye-related BA testing. Here, we provide an analysis of the current literature and suggestions for further directions in the development of high-capacity, cost-effective, and highly predictive nonclinical models of eye-related drug BA. One, or a combination of these models, has the potential for routine use in research laboratories and/or the pharmaceutical industry to overcome various obstacles in reformulated OP development and registration.
Department of Pharmaceutical Technology, Faculty of Pharmacy and Biochemistry, University of Zagreb, Zagreb, Croatia. Electronic address: ipepic@pharma.hr.
Ivan
I
Pepić
Department of Pharmaceutical Technology, Faculty of Pharmacy and Biochemistry, University of Zagreb, Zagreb, Croatia. Electronic address: jlovric@pharma.hr.
Jasmina
J
Lovrić
Generics R&D, PLIVA Croatia Ltd, TEVA Group Member, Zagreb, Croatia.
Biserka
B
Cetina-Čižmek
Institut für Pharmazeutische Technologie, Technische Universität Braunschweig, Braunschweig, Germany.
Stephan
S
Reichl
Department of Pharmaceutical Technology, Faculty of Pharmacy and Biochemistry, University of Zagreb, Zagreb, Croatia.
Jelena
J
Filipović-Grčić
D060433:Administration, Ophthalmic; D000818:Animals; D001682:Biological Availability; D005123:Eye / Q000187:drug effects* / Q000378:metabolism*; D006801:Humans; D008954:Models, Biological; D010539:Permeability / Q000187:drug effects; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000378:metabolism*
D004364:Pharmaceutical Preparations