Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies

For oral drug products, in vitro dissolution is the most used surrogate of in vivo dissolution and absorption. In the context of drug product quality, safe space is defined as the boundaries of in vitro dissolution, and relevant quality attributes, within which drug product variants are expected to...

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Veröffentlicht in:	Journal of pharmaceutical sciences 2021-12, Vol.110 (12), p.3896-3906
Hauptverfasser:	Heimbach, Tycho, Kesisoglou, Filippos, Novakovic, Jasmina, Tistaert, Christophe, Mueller-Zsigmondy, Martin, Kollipara, Sivacharan, Ahmed, Tausif, Mitra, Amitava, Suarez-Sharp, Sandra
Format:	Artikel
Sprache:	eng
Schlagworte:	Administration, Oral Bioavailability Bioequivalence Biopharmaceutics Biopharmaceutics - methods Dissolution model(s) Dosage Forms Drug Liberation In Vitro-In Vivo Correlation(s) (IVIVC) Models, Biological Particle size Physiologically Based Pharmacokinetic (PBPK) modeling Solubility Therapeutic Equivalency
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