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 GuidanceChapter 1. Waiver of In Vivo Bioequivalence StudyChapter 2. Quality Risk ManagementChapter 3. Pharmaceutical Quality SystemChapter 4. Pharmaceutical DevelopmentChapter 5. Scale-Up and Postapproval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing EquipmentChapter 6. Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsChapter 7. Validation of Analytical ProceduresChapter 8. Bioequivalence Testing of Topical DrugsChapter 9. Active Pharmaceutical Ingredients: GMP Compliance and InspectionChapter 10. Test Procedures and Acceptance Criteria for New Chemical Drug Substances and Drug ProductsChapter 11. Topical Testing of Transdermal Drug ProductsChapter 12. Impurities Profiling: Drug SubstanceChapter 13. Impurities in New Drug ProductsChapter 14. Formulation Factors in Semisolid Dosage FormsChapter 15. Pediatric Research Equity Act (PREA) ComplianceChapter 16. Global Regulatory Guidance on Bioequivalence TestingChapter 17. Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs – General ConsiderationsChapter 18. FDA 483 ObservationsChapter 19. WHO Good Manufacturing GuidelinesAppendicesPart II Manufacturing FormulationsSemisolid FormulationsPart III Commercial Pharmaceutical FormulationsCommercial Pharmaceutical Formulations