In vitro-in vivo correlations

About this book

The 26 invited and contributed papers explore the relationship between in-vitro and in-vivo reactions to extended release drugs, especially as they relate to determining sufficient and safe dosage. Among the topics are the theory and case studies of dissolution assay development, a general framework for various types of deconvolution methods, determining critical manufacturing and formation variables for a hydrophilic matrix tablet formulation using an in-vitro discriminatory dissolution method, a comparison of methodologies for evaluating regional intestinal permeability, and the impact of correlations on product development and regulatory agencies.