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

Manufacturing Considerations in Liquid Formulations

Oral Solutions and Suspensions

The FDA Drug Product Surveillance Program

Changes to Approved NDAs and aNDAs

Formulation Considerations of Liquid Products

Container Closure Systems

Material for Containers

Stability Testing of New Drug Substances and Products

Stability Testing: Photostability Testing of New Drug Substances and Products

Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products

Evaluation of Stability Data

Stability Data Package for Registration Applications in Climatic Zones III and IV

EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use

Impurities: Guideline for Residual Solvents

Electronic Records and Signatures (CFR 21 Part 11 Compliance)

Product-Specific Bioequivalence Testing Protocols

Formulation Considerations

Pediatric Pharmaceutical EU Legislation

Pediatric Formulations

SOP and Specification to Establish Electronic Submission to Regulatory Agencies

Part II: Manufacturing Formulations

Part III: Commercial Pharmaceutical Products