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dc.contributor.authorMetry, Melissa
dc.contributor.authorPolli, James E
dc.date.accessioned2022-01-18T21:05:17Z
dc.date.available2022-01-18T21:05:17Z
dc.date.issued2022-01-05
dc.identifier.urihttp://hdl.handle.net/10713/17507
dc.description.abstractThe objective of this review article is to summarize literature data pertinent to potential excipient effects on intestinal drug permeability and transit. Despite the use of excipients in drug products for decades, considerable research efforts have been directed towards evaluating their potential effects on drug bioavailability. Potential excipient concerns stem from drug formulation changes (e.g., scale-up and post-approval changes, development of a new generic product). Regulatory agencies have established in vivo bioequivalence standards and, as a result, may waive the in vivo requirement, known as a biowaiver, for some oral products. Biowaiver acceptance criteria are based on the in vitro characterization of the drug substance and drug product using the Biopharmaceutics Classification System (BCS). Various regulatory guidance documents have been issued regarding BCS-based biowaivers, such that the current FDA guidance is more restrictive than prior guidance, specifically about excipient risk. In particular, sugar alcohols have been identified as potential absorption-modifying excipients. These biowaivers and excipient risks are discussed here. [Figure not available: see fulltext.] © 2022, The Author(s).en_US
dc.description.urihttps://doi.org/10.1208/s12248-021-00670-1en_US
dc.language.isoenen_US
dc.publisherSpringer Natureen_US
dc.relation.ispartofAAPS Journalen_US
dc.rights© 2022. The Author(s).en_US
dc.subjectBiopharmaceutics Classification System (BCS)en_US
dc.subjectbioavailabilityen_US
dc.subjectbioequivalenceen_US
dc.subjectbiowaiveren_US
dc.subjectexcipienten_US
dc.titleEvaluation of Excipient Risk in BCS Class I and III Biowaivers.en_US
dc.typeArticleen_US
dc.identifier.doi10.1208/s12248-021-00670-1
dc.identifier.pmid34988701
dc.source.journaltitleThe AAPS journal
dc.source.volume24
dc.source.issue1
dc.source.beginpage20
dc.source.endpage
dc.source.countryUnited States


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