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