Book Description
An expertly written source on the devices, systems, and technologies used in the dissolution testing of oral pharmaceutical dosage forms, this reference provides reader-friendly chapters on currently utilized equipment, equipment qualification, consideration of the gastrointestinal physiology in test design, the analysis and interpretation of data and procedure automation -laying the foundation for the creation of appropriate and useful dissolution tests according to the anticipated location and duration of drug release from the dosage form within the gastrointestinal tract.
Table of Contents
1 Historical development of dissolution testing 1
2 Compendial testing equipment : calibration, qualification, and sources of error 39
3 Compendial requirements of dissolution testing – European pharmacopoeia, Japanese pharmacopeia, United States pharmacopoeia 69
4 The role of dissolution testing in the regulation of pharmaceuticals : the FDA perspective 81
5 Gastrointestinal transit and drug absorption 97
6 Physiological parameters relevant to dissolution testing : hydrodynamic considerations 127
7 Development of dissolution tests on the basis of gastrointestinal physiology 193
8 Orally administered drug products : dissolution data analysis with a view to in vitro-in vivo correlation 229
9 Interpretation of in vitro-in vivo time profiles in terms of extent, rate, and shape 251
10 Study design considerations for IVIVC studies 281
11 Dissolution method development with a view to quality control 315
12 Dissolution method development : an industry perspective 351
13 Design and qualification of automated dissolution systems 373
14 Bioavailability of ingredients in dietary supplements : a practical approach to the in vitro demonstration of the availability of ingredients in dietary supplements 407
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