Lowly-buffered biorelevant dissolution testing is not necessarily biopredictive of human bioequivalence study outcome: Relationship between dissolution and pharmacokinetics
Kazuki Matsui, Katsuki Nakamichi, Masatoshi Nakatani, Hiroyuki Yoshida, Shinji Yamashita, Shoji Yokota
Topics & Concepts
BioequivalenceDissolutionDissolution testingIVIVCChemistryChromatographyPharmacokineticsPharmacologyBiopharmaceuticalBiopharmaceutics Classification SystemMedicineBiotechnologyOrganic chemistryBiologyDrug Solubulity and Delivery SystemsCrystallization and Solubility StudiesGastrointestinal motility and disorders