Handbook of Preformulation(2nd Edition) Chemical, Biological, and Botanical Drugs, Second Edition by NiaziSarfarazK. Hardcover, 574 Pages, Published 2019 by Crc Press ISBN-13: 978-1-138-29755-5, ISBN: 1-138-29755-0
"Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development. Entirely focused on preformulation principles, this fully revised a ..."
Mrna Therapeutics(1st Edition) Fast-To-Market Strategies by Niazi, SarfarazK. Hardcover, 304 Pages, Published 2022 by Crc Press ISBN-13: 978-1-03-216344-4, ISBN: 1-03-216344-5
"Biological drug and vaccine manufacturing has quickly become one of the highest-value fields of bioprocess engineering, and many bioprocess engineers are now finding job opportunities that have traditionally gone to chemical engineers. Fundamentals of Modern Bioprocessing addresses this growing demand. Written by experts well-established in the field, this book connects the principles and applications of bioprocessing engineering to he ..."
"What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Str ..."
"Providing methodologies that can serve as a reference point for new formulations, the second volume covers uncompressed solids, which include formulations of powders, capsules, powders ready for reconstitution, and other similar products.Highlights from Uncompressed Solid Products, Volume Two include:the fundamental issues of good manufacturing practicesformulations for more than 400 pharmaceutical products, including currently approved ..."
"The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this first volume of a six-volume set, compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to c ..."
Biosimilar and Interchangeable Biologics(1st Edition) Biosimilars and Interchangeable Biologics: Tactical Elements (Volume 1) by SarfarazK. Niazi Hardcover, 623 Pages, Published 2015 by Crc Press ISBN-13: 978-1-4987-4349-5, ISBN: 1-4987-4349-8
"What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Tac ..."
The Omega Connection The Facts About Fish Oils and Human Health by Sarfaraz Khan Niazi Hardcover, 187 Pages, Published 1987 by Esquire Books ISBN-13: 978-0-9617841-0-2, ISBN: 0-9617841-0-5
"Over-the-Counter products comprise a special category of healthcare products. While these formulations have much in common with their prescription counterparts, they are presented in this series separately because of their development approach taken, labeling considerations required, and support available from suppliers of ingredients in designing these products.Highlights from Over-the-Counter Products, Volume Five include:solids, liqu ..."
"As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence ..."
"Because of many misconceptions, the biological drug manufacturing industry does not fully utilize disposable components, despite their wide availability. These misconceptions include concerns for the quality of materials, running costs, scalability, the level of automation possible, and the training of staff needed to include these components in existing bioprocessing systems. Not fully realizing the long-term benefits, many manufacture ..."
"As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequival ..."