Research Topics
| Robbe C LyonSummaryAffiliation: Food and Drug Administration Country: USA Publications
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Detail Information
Publications
Stability profiles of drug products extended beyond labeled expiration datesRobbe C Lyon
Division of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, HFD 941, White Oak, Life Sciences Building 64, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993 0002, USA
J Pharm Sci 95:1549-60. 2006..Due to the lot-to-lot variability, the stability and quality of extended drug products can only be assured by periodic testing and systematic evaluation of each lot...
Comparative stability of repackaged metoprolol tartrate tabletsYongsheng Yang
Food and Drug Administration, Center for Drug Evaluation and Research, Division of Product Quality Research, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States
Int J Pharm 385:92-7. 2010..Study results suggest product quality can be negatively impacted even when using USP Class A repackaging materials...- Quantitative determination of cesium binding to ferric hexacyanoferrate: Prussian bluePatrick J Faustino
Division of Product Quality Research, Office of Testing and Research, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
J Pharm Biomed Anal 47:114-25. 2008..These physiochemical properties can be utilized as quality attributes to monitor and predict drug product quality under certain manufacturing and storage conditions and may be utilized to enhance the clinical efficacy of PB... - Measuring the distribution of density and tabletting force in pharmaceutical tablets by chemical imagingChristopher D Ellison
Division of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States
J Pharm Biomed Anal 48:1-7. 2008..This work demonstrates that near-infrared chemical imaging can be an effective tool in monitoring not only the physical quality of pharmaceutical tablets, but the corresponding die forces controlling tabletting and final ejection... - Quantitative determination of thallium binding to ferric hexacyanoferrate: Prussian blueYongsheng Yang
Food and Drug Administration, Center for Drug Evaluation and Research, Office of Testing and Research, Division of Product Quality Research, Silver Spring, MD 20993, USA
Int J Pharm 353:187-94. 2008..These findings can be utilized to evaluate and predict drug product quality under certain manufacturing and dry storage conditions... - Biopharmaceutics classification of selected beta-blockers: solubility and permeability class membershipYongsheng Yang
Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA
Mol Pharm 4:608-14. 2007..In addition, the difference between the tightness of the intercellular junction in vivo and in vitro may partially contribute to this disparity in the sotalol permeability of in vivo and in vitro... - Drug product characterization by macropixel analysis of chemical imagesMazen L Hamad
Division of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
J Pharm Sci 96:3390-401. 2007..Both imaging-based algorithms provide useful quantitative information about the heterogeneity of pharmaceutical products... - Quality assessment of internet pharmaceutical products using traditional and non-traditional analytical techniquesBenjamin J Westenberger
Food and Drug Administration, Division of Pharmaceutical Analysis, 1114 Market Street, St Louis, MO 63101, USA
Int J Pharm 306:56-70. 2005..For example, these methods detected suspect manufacturing issues (such as blending), which were not evident from traditional testing alone... - Functionality of magnesium stearate derived from bovine and vegetable sources: dry granulated tabletsMazen L Hamad
Division of Product Quality Research, Office of Pharmaceutical Science, Food and Drug Administration, Life Science Building 64, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA
J Pharm Sci 97:5328-40. 2008..The results indicated that magnesium stearate interchangeability with respect to lubricant efficiency depends upon the level in which it is used and the manufacturing method... - Validation of an in vitro method for the determination of cyanide release from ferric-hexacyanoferrate: Prussian blueYongsheng Yang
Food and Drug Administration, Center for Drug Evaluation and Research, Division of Product Quality Research, Silver Spring, MD 20993, USA
J Pharm Biomed Anal 43:1358-63. 2007..05 to 0.5 ppm (mg/L). The R(2) ranged from 0.9925 to 0.9998. This validated method was successfully implemented to determine cyanide release from PB under various pH conditions (from 1.0 to 12) at different time-points (from 1 to 24 h)... - Determination of plasma and brain levels of isotretinoin in mice following single oral dose by high-performance liquid chromatographyYongsheng Yang
Food and Drug Administration, Center for Drug Evaluation and Research/Division of Product Quality Research, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
J Pharm Biomed Anal 37:157-63. 2005..The maximum concentrations in plasma and brain were 2.36 microg/mL and 0.34 microg/g, respectively. The mean area under curve (AUC) in plasma was 6.13 microg h/mL. The mean eliminate half-life in plasma was estimated as 46 min... 
Near-infrared spectral imaging for quality assurance of pharmaceutical products: analysis of tablets to assess powder blend homogeneityRobbe C Lyon
Division of Product Quality Research, Food and Drug Administration, Kensington, MD 20895, USA
AAPS PharmSciTech 3:E17. 2002..The technique has potential for a variety of applications in product quality assurance and could affect the control of manufacturing processes...