Zheng, Jack
Formulation and Analytical Development for Low-Dose Oral Drug Products
There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.
Keywords: Jack Zheng, low-dose oral drug products, regulation of low-dose oral drug products, formulation of low-dose oral drug products, manufacture of low-dose oral drug products, analytical chemistry of low-dose oral drug products, low-dose drugs, regulation of low-dose drugs, formulation of low-dose drugs, manufacture of low-dose drugs
- Author(s)
- Zheng, Jack
- Publisher
- John Wiley and Sons, Inc.
- Publication year
- 2009
- Language
- en
- Edition
- 1
- Page amount
- 432 pages
- Category
- Technology, Energy, Traffic
- Format
- Ebook
- eISBN (PDF)
- 9780470386354