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In Silico and Experimental Methods to Support Generic Nasal Drug Product (NDP) Development

Walenga RL, Dhapare S, Newman B, Babiskin A, Zhao L.

Respiratory Drug Delivery 2021. Volume , 2021: 141-150.

Abstract:

The Office of Generic Drugs (OGD) at the U.S. Food and Drug Administration (FDA) manages and supports several external and internal research projects dedicated to improving efficiency of generic nasal drug product (NDP) development, as well as to better understand bioequivalence (BE) of these products. Many of these projects have focused on the development of in silico hybrid computational fluid dynamics (CFD) and physiologically-based pharmacokinetic (PBPK) models as well as in vitro nasal model replicas that may be used for measuring regional deposition following NDP administration. These in silico and in vitro tools are useful for understanding the relationships between in vitro test metrics and in vivo performance as represented by regional deposition in addition to local and systemic pharmacokinetics (PK). The intent is for these in silico and in vitro models to provide generic NDP developers with additional information, where effective models may guide decisions on any necessary device and formulation changes prior to conducting any in vivo studies, which may consequently reduce the cost and time for development of generic NDPs.