Full Description
Introduction to Pharmaceutical Technology Development: Journey from Lab to Shelf of Commercial Pharmaceutical Drugs is a complete reference and learning resource for those working in pharmaceutics or aspiring to join the industry. The book provides a comprehensive view into all aspects of drug discovery, approval, and production. Using examples of well-known drugs and their journeys from lab to market, the book provides a comprehensive overview of all steps involved in bringing new drugs, including biologics, to the shelves.
Topics covered include Drug Discovery, Pharmaceutical Formulations of Different Dose Form, Analytical Testing and Development, Unit Operations and Design for Major Equipment, Basics of Analytics and Process Validations and Protocols (DQ, IQ, OQ, PQ) in FDA-Regulated Industries.
This book provides graduate students from several areas with a solid foundation of the Pharmaceutic industry across key stages on new drug lifecycle.
Contents
1. Modern-Day Drug Discovery
2. Pharmaceutical Formulation of Dosage Forms
3. Analytical Testing and Development
4. Unit Operations and Design for Pharmaceuticals Manufacturing and production
5. Basics of Analytics and Process Validations and Protocols (DQ, IQ, OQ, PQ) in FDA-Regulated Industries
6. Case Studies in Validation and Protocols of Pharmaceutical Industry
7. Formulation, Manufacturing and Packaging of Pharmaceutical Dosage Forms
8. Basics of Biopharmaceuticals Development, Production, and Quality.
9. Key Unit Operations in Biopharmaceuticals Productions
10. Overview of Good Manufacturing Practice (GMP)
11. Clinical Research: Ethics & Regulatory Affair
12. Journey from Lab to Shelf: Omeprazole, Atorvastatin-Calcium, Acetazolamide, Allopurinol, Adacel
13. Journey from Lab to Shelf: Amoxicillin, Alprazolam, Penicillin, Acetaminophen, Metformin
