Generic Drug Product Development: Specialty Dosage Forms

Exploring the more difficult demonstration of pharmaceutical equivalence and bioequivalence for specialty drug products, this title details various approaches and strategies for manufacturers to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. It discusses the measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, generic biologics, and other drug products.

• Introduction
• Non-Systematically Absorbed Oral Drug Products
• Topical dosage forms: Manufacture and Regulatory Issue
• Topical Dosage Forms: Bioequivalence Assessment
• Suppositories
• Nasal and Inhalation Products: Manufacture
• Nasal and Inhalation Drug Products – Regulatory and Bioequivalence
• Transdermal Drug Delivery
• Modified Release Parenteral Products
• Generic Biologies: Manufacture
• Generic Biologies: Regulatory Issues