Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery

CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):552-555. doi: 10.1002/psp4.12930. Epub 2023 Feb 9.

Authors

Miyoung Yoon¹, Andrew Babiskin¹, Meng Hu¹, Fang Wu¹, Sam G Raney², Lanyan Fang¹, Liang Zhao¹

Affiliations

¹ Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
² Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

No abstract available

MeSH terms

Biological Availability
Drug Delivery Systems*
Drug Liberation
Humans
Therapeutic Equivalency