Handbook of Cosmetic Science and Technology: This book is written by Sarfaraz K. Niazi. You can download it freely in pdf format. No industry in the world is more regulated than the pharmaceutical industry due to the potential threat to a patient’s life from the use of pharmaceuticals. The cost of bringing a new chemical entity to final regulatory approval is $800 million, making the pharmaceutical industry one of the most research-intensive industries in the world. The industry is anticipated to spend about $20 billion on research and development in 2004. With patent protection on many drugs set to expire, the generic drug market is becoming one of the fastest-growing segments of the drug industry. the pharmaceutical industry with all the big multinational companies. have a significant presence in this field
It is limited by time, but formulating drugs into desirable dosage forms remains an area where convenience can be practiced by those who master the skills of pharmaceutical formulations. The Handbook of Pharmaceutical Manufacturing Formulations is the first major attempt to consolidate the available formulation knowledge into one comprehensive and, by nature, rather voluminous presentation.
Overview of Handbook of Cosmetic Science and Technology 3rd Edition Pdf Free
According to Sarfaraz K. Niazi, the book is divided into six volumes based strictly on the type of formulation science involved in the development of these dosage forms: sterile products, compressed solids, uncompressed solids, liquid products, semi-solid products, and over-the-counter products ( OTC). Although they can easily fall into one of the other five categories, OTC products are considered separately to meet industry standards for independent research divisions for OTC products. Sterile products require skills related to product sterilization; Of less importance is the issue of bioavailability, which is an inherent problem with compressed dosage forms. These types of considerations have led pharmaceutical products to be classified into these six categories. Each volume includes a description of the regulatory filing techniques for the described formulations. Regulatory guidelines are also included.
The book is divided into six volumes based strictly on the type of formulation science involved in the development of these dosage forms: sterile products, compressed solids, uncompressed solids, liquid products, semi-solid products, and over-the-counter products ( OTC). Although they can easily fall into one of the other five categories, OTC products are considered separately to meet industry standards for independent research divisions for OTC products. Sterile products require skills related to product sterilization; Of less importance is the issue of bioavailability, which is an inherent problem with compressed dosage forms. These types of considerations have led pharmaceutical products to be classified into these six categories. Each volume includes a description of the regulatory filing techniques for the described formulations. Regulatory guidance on cGMP compliance specific to the dosage form and advice on how to scale up production lots are also included.
Topics of this Edition
Part I. Regulatory and Manufacturing Guidelines
Chapter 1. U.S. FDA Good Manufacturing Practices
Chapter 2. Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use
Chapter 3. Process Validation: General Principles and Practices
Chapter 4. Bioequivalence Regulatory Compliance
Chapter 5. Bioequivalence Regulatory Review Process and Audit
Chapter 6. EU Guidelines to Good Manufacturing Practice: Active Drug Substance
Chapter 7. FDA Pre-approval Inspections
Chapter 8. Formulation Factors in Uncompressed Dosage Forms
Chapter 9: Solid-State Properties.
Chapter 10: Formulation of Flavor.
Part II. Manufacturing Formulations
Uncompressed Solids Formulations
Part III. Commercial Pharmaceutical Formulations.
About the Author
Sarfaraz K. Niazi is a recognized authority on the development of medicines and dosage forms, including biological medicines and alternative medicines. He is the founder and CEO of Adello Biologics, LLC (formerly Therapeutic Proteins International, LLC), a biosimilars company located in Chicago, IL, Piscataway, NJ, and Cashel, Ireland. As an entrepreneur, Niazi has raised hundreds of millions of dollars and was recognized as a member of the Chicago Entrepreneur Hall of Fame. Niazi began his career teaching pharmaceutical sciences at the University of Illinois College of Pharmacy, where he held a position before entering the industry. at Abbott International. He left Abbott as an Abbott Volwiler Fellow to pursue his passion, first through global consulting and later through founding a biosimilars company.
A prolific inventor with dozens of patents, primarily in the field of bioprocessing technology, Niazi is currently the largest bioprocess technology patent holder. 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 the development of chemical, botanical, and biological products, from discovery to regulatory approval. With over 50 ISBNs under his name, Niazi is the author of many landmark books in the field of pharmaceutical sciences.
He currently serves as an 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 HEJ Research Institute, Karachi. He is a member of the editorial board of the MOJ Proteomics & Bioinformatics (MOJPB) journal and, as of 2017, editor-in-chief of the International Journal of Biosimilars. He also serves as a member of the National Advisory Board for the University of Illinois College of Pharmacy. He is a member of the Pakistan Academy of Medical Sciences, a member of the National Academy of Clinical Biochemistry, and the Institute of Biology. He served as a TOKEN Fellow in India (Transfer of Knowledge through Expatriate Citizens (UNDP). In 2013, he received one of the highest civilian awards, the Star of Distinction in Engineering, from the President of Pakistan. He has hosted a radio show in Voice of America (US Department of State) weekly for over 5 years with an audience in the billions.
