Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
CRC Press (Verlag)
978-1-032-92018-4 (ISBN)
Features:
¿ Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions
¿ Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing
¿ Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements
¿ Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines
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
Erscheinungsdatum | 16.10.2024 |
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Verlagsort | London |
Sprache | englisch |
Maße | 210 x 280 mm |
Gewicht | 843 g |
Themenwelt | Medizin / Pharmazie ► Allgemeines / Lexika |
Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie | |
Naturwissenschaften ► Biologie | |
Technik ► Umwelttechnik / Biotechnologie | |
ISBN-10 | 1-032-92018-1 / 1032920181 |
ISBN-13 | 978-1-032-92018-4 / 9781032920184 |
Zustand | Neuware |
Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
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