Looking at the practical and theoretical aspects of pharmaceutical scale-up, this third edition examines the procedures required to move a pharmaceutical product from the research and development stage into production. Applying the theory of dimensional analysis, this comprehensive text looks at the regulations and practices of various batch enlargement techniques, while also reviewing issues of post-approval changes.This is an essential guide for all those involved in product development and manufacturing.
Revised and updated, this new edition includes : Substantial revisions of every chapter. New chapters on scale-up and quality risks, process validation, and virtual scale-up of manufacturing solid dosage forms. New material regarding tableting scale-up and compaction. Appendices covering FDA and EU Guidelines. Discussion of SUPAC, PAT, and QbD initiatives for scale-up. Practical advice on scale-up solutions from world-renowned experts in the field.
Looking at the practical and theoretical aspects of pharmaceutical scale-up, this third edition examines the procedures required to move a pharmaceutical product from the research and development stage into production. Applying the theory of dimensional analysis, this comprehensive text looks at the regulations and practices of various batch enlargement techniques, while also reviewing issues of post-approval changes.This is an essential guide for all those involved in product development and manufacturing.
Revised and updated, this new edition includes : Substantial revisions of every chapter. New chapters on scale-up and quality risks, process validation, and virtual scale-up of manufacturing solid dosage forms. New material regarding tableting scale-up and compaction. Appendices covering FDA and EU Guidelines. Discussion of SUPAC, PAT, and QbD initiatives for scale-up. Practical advice on scale-up solutions from world-renowned experts in the field.
