Analytical Scientists In Pharmaceutical Product Development

Download or read book Formulation and Analytical Development for Low-Dose Oral Drug Products written by Jack Zheng and published by John Wiley & Sons. This book was released on 2009-02-09 with total page 506 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.