Justification of disintegration testing beyond current FDA criteria using in vitro and in silico models

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Uebbing,Lukas; Klumpp,Lukas; Webster,Gregory K; Löbenberg,Raimar;
  • Publisher: Dove Medical Press
  • Journal: Drug Design, Development and Therapy, volume 11, pages 1,163-1,174 (issn: 1177-8881, eissn: 1177-8881)
  • Publisher copyright policies & self-archiving
  • Identifiers: pmc: PMC5395276, doi: 10.2147/DDDT.S131213
  • Subject: product specification | dissolution | Quality by Design | Drug Design, Development and Therapy | model fitting | RM1-950 | Therapeutics. Pharmacology | DDDPlus | Original Research | API | disintegration | quality-by-design
    • ddc: ddc:610

Lukas Uebbing,1,2,* Lukas Klumpp,1,3,* Gregory K Webster,4 Raimar Löbenberg1 1Faculty of Pharmacy and Pharmaceutical Sciences, Katz Group-Rexall Centre for Pharmacy and Health Research, University of Alberta, Edmonton, Canada; 2Institute of Pharmacy and Bioche... View more
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