Affiliation: Food and Drug Administration
- Generic omeprazole delayed-release capsules: in vitro performance evaluationsTerry Moore
Office of Testing and Research, Division of Pharmaceutical Analysis, Food and Drug Administration, St Louis, MO 63101, USA
Drug Dev Ind Pharm 35:917-21. 2009..FDA has received some complaints concerning a lack of therapeutic effect of the generic omeprazole delayed-release capsules. Aim: To investigate the quality of five different marketed generic omeprazole delayed-release capsules...
- Gauge repeatability and reproducibility for accessing variability during dissolution testing: a technical noteZongming Gao
Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St Louis, MO 63101, USA
AAPS PharmSciTech 8:E82. 2007
- Delayed release tablet dissolution related to coating thickness by terahertz pulsed image mappingJohn A Spencer
U S Food and Drug Administration, Division of Pharmaceutical Analysis, 1114 Market Street, St Louis, Missouri 63101, USA
J Pharm Sci 97:1543-50. 2008..The speed and ease of TPI mapping may make it an attractive replacement for wet dissolution testing both in product development and eventually for process analysis...
- Identification of amino-tadalafil and rimonabant in electronic cigarette products using high pressure liquid chromatography with diode array and tandem mass spectrometric detectionMichael E Hadwiger
Food and Drug Administration, Division of Pharmaceutical Analysis, 1114 Market St, Saint Louis, MO 63101, USA
J Chromatogr A 1217:7547-55. 2010..Identification was accomplished by comparing the retention time of relevant peaks in the sample with those of standard compounds, in addition to comparison of the UV spectra, mass spectra and/or product ion mass spectra...