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.
1. Title of Book - p. i 2. Cover image - p. i 3. Title page - p. ii 4. Table of Contents - p. iii 5. Copyright - p. iv 6. Preface - p. xv 7. Acknowledgment - p. xxi 8. Chapter 1. The modern-day drug discovery - p. 1 9. Chapter 2. Pharmaceutical product formulation of different dosage forms - p. 41 10. Chapter 3. Analytical testing and development in pharmaceutical technology - p. 75 11. Chapter 4. Unit operations and design for pharmaceuticals manufacturing and production - p. 111 12. Chapter 5. Basics of process validation and equipment qualification protocols (DQ, IQ, OQ, PQ) in FDA-regulated industries - p. 139 13. Chapter 6. Case studies in validation and protocols of pharmaceutical industry - p. 171 14. Chapter 7. Formulation, manufacturing and packaging of pharmaceutical dosage forms - p. 205 15. Chapter 8. Basics of biopharmaceuticals development, production, and quality - p. 245 16. Chapter 9. Key unit operations in biopharmaceuticals productions - p. 287 17. Chapter 10. Overview of good manufacturing practices (GMP) - p. 317 18. Chapter 11. Clinical research: Ethics & regulatory affair - p. 351 19. Chapter 12. Journey from lab to shelf: Omeprazole, Atorvastatin-Calcium, Acetazolamide, Allopurinol, Adacel - p. 381 20. Chapter 13. Journey from lab to shelf: Amoxicillin, Alprazolam, Penicillin, Acetaminophen, Metformin - p. 419 21. Index - p. 451
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.
1. Title of Book - p. i 2. Cover image - p. i 3. Title page - p. ii 4. Table of Contents - p. iii 5. Copyright - p. iv 6. Preface - p. xv 7. Acknowledgment - p. xxi 8. Chapter 1. The modern-day drug discovery - p. 1 9. Chapter 2. Pharmaceutical product formulation of different dosage forms - p. 41 10. Chapter 3. Analytical testing and development in pharmaceutical technology - p. 75 11. Chapter 4. Unit operations and design for pharmaceuticals manufacturing and production - p. 111 12. Chapter 5. Basics of process validation and equipment qualification protocols (DQ, IQ, OQ, PQ) in FDA-regulated industries - p. 139 13. Chapter 6. Case studies in validation and protocols of pharmaceutical industry - p. 171 14. Chapter 7. Formulation, manufacturing and packaging of pharmaceutical dosage forms - p. 205 15. Chapter 8. Basics of biopharmaceuticals development, production, and quality - p. 245 16. Chapter 9. Key unit operations in biopharmaceuticals productions - p. 287 17. Chapter 10. Overview of good manufacturing practices (GMP) - p. 317 18. Chapter 11. Clinical research: Ethics & regulatory affair - p. 351 19. Chapter 12. Journey from lab to shelf: Omeprazole, Atorvastatin-Calcium, Acetazolamide, Allopurinol, Adacel - p. 381 20. Chapter 13. Journey from lab to shelf: Amoxicillin, Alprazolam, Penicillin, Acetaminophen, Metformin - p. 419 21. Index - p. 451
