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Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Lemborexant.

Autor: Beran K; Fraunhofer Institute for Translational Medicine and Pharmacology, Frankfurt am Main, Germany., Abrahamsson B; Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca Gothenburg, Sweden., Charoo N; Aramed, 216-laboratory complex, Dubai Science Park, UAE., Cristofoletti R; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, Florida 32827, USA., Holm R; University of Southern Denmark, Department of Physics, Chemistry and Pharmacy, Odense, Denmark., Kambayashi A; Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Japan., Langguth P; Institute of Pharmacy, Johannes Gutenberg University, Mainz, Germany., Mehta M; United States Food and Drug Administration, Centre for Drug Evaluation and Research, Silver Spring, Maryland 20993, USA., Parr A; BioCeutics LLC, Acworth, Georgia 30101, USA., Polli JE; Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, Maryland 20742, USA., Shah VP; Pharmaceutical Consultant, North Potomac, MD, USA., Dressman J; Fraunhofer Institute for Translational Medicine and Pharmacology, Frankfurt am Main, Germany. Electronic address: Dressman@em.uni-frankfurt.de.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2024 Oct 23. Date of Electronic Publication: 2024 Oct 23.