Applications of the In vitro Dissolution and Absorption System 2 (IDAS2) as a Bioequivalence Biowaiver Tool
Applications of the In vitro Dissolution and Absorption System 2 (IDAS2) as a Bioequivalence Biowaiver Tool
Carlos Jiménez-Romero1, Blanca M. Gálvez1, Johayra Simithy1, Geraldin Martínez1, Andrea Pravia1, Daniel Álvarez2, Pablo N. Solís2, Jibin Li3, Ismael J. Hidalgo1,3
1Absorption Systems Panama (ASP), Panama City, Panama.
2Laboratorios Medipan S.A, Panama City, Panama.
3Absorption Systems LLC (AS), Exton, Pennsylvania, United States.
This poster was presented at AAPS PharmSci 360, November 2018.
In vitro comparative dissolution profiles (CDP) are widely accepted to ensure product quality and consistency and to assess bioequivalence (BE) in vitro. This regulatory acceptance of in vitro testing as a reliable surrogate for in vivo BE is referred as “Biowaiver”. Since highly soluble compounds in dosage forms rapidly dissolving at physiological pH are expected to exhibit minimal bioavailability problems, BCS class I and class III drug formulations are candidates for biowaiver.
