Generic Drug Product Development
Solid Oral Dosage Forms
edited by Leon Shargel
and Izzy Kanfer

Keeping pace with the latest technologies in the field, this guide describes the development of solid oral generic drug products from project initiation to market approval-collecting in-depth discussions from more than 30 noted specialists on topics such as quality control and quality assurance, experimental formulation, pharmaceutical ingredients, drug delivery, and bioequivalence.

Highlights constraints in generic drug development that differ from the formulation design of a brand name pharmaceutical product.

Focusing on immediate-release and modified-release dosage forms, Generic Drug Product Development

• Outlines a variety of legal, regulatory, and patent challenges presented by the brand name pharmaceutical industry
• Describes scale-up, post-approval changes, and post-marketing surveillance
• Considers key elements in the formulation of generic drug products including the availability of raw materials, chemical purity, the polymorphic form and particle size of active pharmaceutical ingredients, and patents of innovator companies
• Details the ANDA regulatory approval process

Generic Drug Product Development is critical reading for all pharmacists; pharmacologists; clinical investigators; pharmaceutical industry professionals involved in clinical, regulatory, statistical, and legal development of generic drugs; and graduate and upper-level undergraduate students who intend to pursue careers in the pharmaceutical industry.

Contents

1. Introduction to Generic Drug Development
2. Active Pharmaceutical Ingredients
3. Analytical Methods Development and Methods Validation for Oral Solid Dosage Forms
4. Experimental Formulation Development
5. Scale-Up, Technology Transfer and Validation
6. Drug Stability
7. Quality Control and Quality Assurance
8. Drug Product Performance, In Vitro
9. ANDA Regulatory Approval Process
10. Bioequivalence and Drug Product Assessment, In Vivo
11. Statistical Considerations for Establishing Bioequivalence
12. Scale-Up, Post Approval Changes, and Post-Marketing Surveillance
13. Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations
14. Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing

Glossary
Index

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