Generic Drug Product Development
Specialty Dosage Forms
edited by Leon Shargel

Generic Drug Product Development: Specialty Dosage Forms focuses on pharmaceutical equivalence and bioequivalence issues for specialty drug products. It provides professionals involved in drug development, regulation, and manufacturing with various approaches to demonstrating therapeutic equivalence of a generic specialty drug product to the brand-name alternative. explores the issues in providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products.

This book discusses 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.

Highlights include:

• a discussion of drug product quality and performance
• an exploration of the more difficult demonstration of pharmaceutical equivalence and bioequivalence for specialty drug products
• a thorough analysis of the FDA requirements of nasal and inhalation drug products

Contents

1. Introduction
2. Nonsystemically Absorbed Oral Drug Products
3. Topical Drug Products—Development,Manufacture and Regulatory Issues
4. Assessment of Topical Dosage Forms Intended for Local or Regional Activity
5. Rectal Dosage Forms and Suppositories
6. Nasal and Inhalation Drug Products
7. Locally Acting Nasal and Inhalation Drug Products: Regulatory and Bioequivalence Perspective
8. Transdermal Dosage Forms
9. Pharmaceutical Development of Modified-Release Parenteral Dosage Forms Using Bioequivalence (BE), Quality by Design (QBD), and In Vitro In Vivo Correlation (IVIVC) Principles
10. Biosimilar Drug Products—Manufacture and Quality

Index

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