Formulation and Analytical Development for Low-dose Oral Drug Products (Repost)
Jack Zheng, "Formulation and Analytical Development for Low-dose Oral Drug Products"
2009 | ISBN-10: 0470056096 | 462 pages | PDF | 7 MB
2009 | ISBN-10: 0470056096 | 462 pages | PDF | 7 MB
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.