Jizhou Wang is chemist at the Division of Life-Cycle API, Office of New Drug Product, Office of Pharmaceutical Quality, Center of Drug Research and Evaluation Center, Food and Drug Administration.
Appendix: Common Deficiencies Related to Solution NMR in the Type-II DMFs
Appendix to Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs, Part I: Solution Nuclear Magnetic Resonance Spectroscopy
Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs
The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.