Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Sarfaraz K. Niazi, Ph.D., a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines. He is Founder and Executive Chairman of Adello Biologics, LLC, (formerly, Therapeutic Proteins International, LLC), a biosimilar products company located in Chicago, IL, Piscataway, NJ and Cashel, Ireland. As an entrepreneur, Niazi has raised hundreds of millions of dollars and became recognized as an inductee into the Chicago Entrepreneur Hall of Fame.Niazi began his career teaching pharmaceutical sciences at the University of Illinois, College of Pharmacy where he was tenured before entering the industry at Abbott International. He departed Abbott as an Abbott Volwiler Fellow to pursue his passion, first through global consulting and later through the founding a biosimilar products company. A prolific inventor with scores of patents, most prominently in the field of bioprocessing technology, Niazi is currently the largest single holder of bioprocess technology patents. His other inventions span a broad category of technologies, new chemical entities, new formulations, new analytical methodologies, and much more. He has hands on experience in developing chemical, botanical and biological products, from discovery to regulatory approval. With over 50 ISBNs under his name, Niazi has authored many landmark books in the field of pharmaceutical sciences. He currently serves as Adjunct Professor at the University of Illinois College of Pharmacy, Ad Hoc faculty at the University of Houston, Texas, the HEJ Research Institute, Karachi, and the National University of Science and Technology, Islamabad. He has also served as a Foreign Professor at the HEJ Research Institute, Karachi. He serves on the editorial board of the journal MOJ Proteomics & Bioinformatics (MOJPB) and starting 2017, as Chief Editor of International Journal of Biosimilars. He also serves as Member of National Advisory Board of the College of Pharmacy, University of Illinois. He is a Fellow of the Pakistan Academy of Medical Sciences, Fellow National Academy of Clinical Biochemistry and Institute of Biology. He served as a TOKTEN Fellow to India (Transfer of Knowledge Through Expatriate Nationals (UNDP). In 2013, he received the one of the highest civilian awards, Star of Distinction in Engineering, from the Pakistani President. He has hosted a radio show at Voice of America (US State Department) on a weekly basis for more than 5 years with audience into billions.

Part I Regulatory and Manufacturing Guidance

Chapter 1. Waiver of In Vivo Bioequivalence Study

Chapter 2. Quality Risk Management

Chapter 3. Pharmaceutical Quality System

Chapter 4. Pharmaceutical Development

Chapter 5. Scale-Up and Postapproval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment

Chapter 6. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Chapter 7. Validation of Analytical Procedures

Chapter 8. Bioequivalence Testing of Topical Drugs

Chapter 9. Active Pharmaceutical Ingredients: GMP Compliance and Inspection

Chapter 10. Test Procedures and Acceptance Criteria for New Chemical Drug Substances and Drug Products

Chapter 11. Topical Testing of Transdermal Drug Products

Chapter 12. Impurities Profiling: Drug Substance

Chapter 13. Impurities in New Drug Products

Chapter 14. Formulation Factors in Semisolid Dosage Forms

Chapter 15. Pediatric Research Equity Act (PREA) Compliance

Chapter 16. Global Regulatory Guidance on Bioequivalence Testing

Chapter 17. Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs – General Considerations

Chapter 18. FDA 483 Observations

Chapter 19. WHO Good Manufacturing Guidelines

Appendices

Part II Manufacturing Formulations

Semisolid Formulations

Part III Commercial Pharmaceutical Formulations

Commercial Pharmaceutical Formulations