Front Cover; Preface; Contents; Chapter 1. Introduction; Chapter 2. Nonsystemically Absorbed Oral Drug Products; Chapter 3. Topical Drug Products -- Development, Manufacture, and Regulatory Issues; Chapter 4. Assessment of Topical Dosage Forms Intended for Local or Regional Activity; Chapter 5. Rectal Dosage Forms and Suppositories; Chapter 6. Nasal and INhalation Drug Products; Chapter 7. Locally Acting Nasal and inhalation Drug Products: Regulatory and Bioequivalence Perspective; Chapter 8. Transdermal Dosage Forms
Chapter 9. Pharmaceutical Development of Modified-Release Parenteral Dosage Forms Using Bioequivalence (BE), Quality by Design (QBD), and In Vitro In Vitro Correlation (IVIVC) Principles Chapter 10. Biosimilar Drug Products -- Manufacture and Quality ; Index; Color Insert ; Back Cover
Summary
Explores the issues in providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products