Pharmaceutical Dissolution Testing

1 Historical development of dissolution testing by Johannes Kramer and Lee Timothy Grady and Jayachandar Gajendran 1
2 Compendial testing equipment : calibration, qualification, and sources of error by Vivian A. Gray 39
3 Compendial requirements of dissolution testing - European pharmacopoeia, Japanese pharmacopeia, United States
pharmacopoeia by William E. Brown 69
4 The role of dissolution testing in the regulation of pharmaceuticals : the FDA perspective by Vinod P. Shah 81
5 Gastrointestinal transit and drug absorption by Clive G. Wilson and Kilian Kelly 97
6 Physiological parameters relevant to dissolution testing : hydrodynamic considerations by Steffen M. Diebold 127
7 Development of dissolution tests on the basis of gastrointestinal physiology by Sandra Klein and Erika Stippler and
Martin Wunderlich and Jennifer Dressman 193
8 Orally administered drug products : dissolution data analysis with a view to in vitro-in vivo correlation by Maria
Vertzoni and Eleftheria Nicolaides and Mira Symillides and Christos Reppas and Athanassios Iliadis 229
9 Interpretation of in vitro-in vivo time profiles in terms of extent, rate, and shape by Frieder Langenbucher 251
10 Study design considerations for IVIVC studies by Theresa Shepard and Colm Farrell and Myriam Rochdi 281
11 Dissolution method development with a view to quality control by Johannes Kramer and Ralf Steinmetz and Erika
Stippler 315
12 Dissolution method development : an industry perspective by Cynthia K. Brown 351
13 Design and qualification of automated dissolution systems by Dale VonBehren and Stephen Dobro 373
14 Bioavailability of ingredients in dietary supplements : a practical approach to the in vitro demonstration of the
availability of ingredients in dietary supplements by V. Srini Srinivasan 407