Crystal City

Global Foundation Inc. Hyatt Regency Crystal City... 

The crystal city is immersed in a soft tesseract of bright stars. 

R.B. Kirsch, Handling of out-of-specification and other unexpected or atypical results, presentation made to AAPS Workshop on Stability Practices, Crystal City,VA, July 1999. 

Jones, R. L., "Movement and Degradation of Aldicarb Residues in Soil and Groundwater," presented at the Environmental Toxicology and Chemistry Conference on Multidisciplinary Aproaches to Environmental Problems, Crystal City, VA. 1983. 

Fast, D.M., Kelley, M., Viswanathan, CT., O Shaughnessy, J., King, S.P., Chaudhary, A., Weiner, R., DeStefano, A.J., and Tang, D. (2009) Workshop report and follow up AAPS workshop on current topics in GLP bioanalysis assay reproducibility for incurred samples implications of Crystal City recommendations. The AAPS Journal, 11,238 241. 

The topic of incurred sample reanalysis (ISR) was introduced at the Crystal City III Conference in May 2006 to help understand the poor reproducibility of results found by FDA in some cases when samples from studies were reanalyzed. The recommendation from the workshop report [10] on this topic is that an adequate evaluation of incurred sample reproducibility should be conducted for each species used for GLP toxicology experiments and in selected clinical studies. It is also recognized that the degree of reproducibility could be different in human samples in comparison to the animal samples. Selection of the studies to be evaluated for ISR was left up to the sponsor. 

The conference report from the Crystal City III Workshop outlines the documentation requirements in detail [10]. The degree of documentation should be sufficient to recreate the validation. Prior to initiating a prestudy validation, an appropriate standard operating procedure or a detailed validation plan should be written. This plan can be a stand-alone document or can be contained in a laboratory notebook or some comparable format. The documentation should clearly state the intended use of the method and a summary of the performance parameters to be validated. The plan should include a summary of the proposed experiments and the target acceptance criteria for each performance parameter evaluated. 

Boulanger, B., Dewe, W., Hubert, P., Govaerts, B., Hammer, C., and Moonen, F. (2006) Objectives of analytical methods, objective of validation and decision rules. AAPS Workshop, Crystal City, VA, May 1 3, 2006. 

Cross-validation is discussed by Viswanathan et al. [2] in the report from the 2006 Crystal City III AAPS workshop/conference Cross-validation procedures and acceptance criteria need to remain flexible considering the various bioanalytical situations where it would be (may be) required. Specific cross-validation criteria should be established a priori in a standard operating procedure (SOP). ... 

Krames M. R. Overview of current status and recent progress of LED technology US Department of Energy Workshop Solid State Lighting — Illuminating the Challenges Crystal City, VA, Nov. 13-14, 2003. 

Before implementation of analytical methods for routine use, careful validation is required to demonstrate that the method is suitable for the intended purpose. Analytical methods employed for the quantitative determination of drug substances and their metabolites in biological media play a significant role in the evaluation and interpretation of pharmacokinetic data. To define the requirements and procedures for the validation of bioanalytical methods, a conference was held in 1990 in Crystal City in the Washington, DC, area, which was co-sponsored by the U.S. Food and Drug Administration (FDA), The Canadian Health Protection Branch, the American Association of Pharmaceutical Scientists (AAPS), and the Association of Official Analytical Chemists (AOAC), bringing together scientists from... 

In a 1992 conference [17], Analytical Methods Validation Bioavailability, Bioequivalence and Pharmacokinetic Studies, held in Crystal City, Washington, DC, the following recommendations were made ... 

The Crystal City 1992 conference [17] recommendation was that if the plasma concentrations of two enantiomers are superimposable, then an enantiospecific assay is not necessary. This recommendation does not distinguish racemic drugs that undergo negligible stereoselective first-pass metabolism from those that undergo extensive and saturable enantiospecific first-pass metabolism. As discussed in detail later, an enantiospecific assay is not necessary in the former case even when the plasma concentrationtime curves for each enantiomer are not superimposable. The AUC of individual enantiomers for such drugs is a fixed ratio of the AUC of total (R -f S). Moreover, superimposability of the rate and extent of absorption entails statistical comparison of the entire shape of the plasma... 

Ghosh, A.K. McGraw, G. 1998. An Approach for Certifying Security in Software Components, Proceedings of 21st NIST-NCSC national information system security conference Crystal City, VA NIST 42-48. Boulder, CO. 

Markezich R.L. and Mundhenke R.F., p. 15, Proc. Fire and Mater. 4" International Conference, Crystal City, VA, November 1995. 

OECD, 2002. Glossary OECD Efficacy Workshop on Certain Antimicrobial Biocides, OECD, Doubletree Hotel Crystal City, Arlington, VA USA. 

Nichols C. E. elal. Uranium geochemical survey in the Crystal City and Beeville quadrangles, Texas. Open File Rep. U.S. Dep. Energy GJBX-19(77), 1977, 326 p. 

GW Anderson. Value added approach to expand markets of spunbonded PP. Proc INDA TEC 96, Crystal City, North Carolina, 1996, pp 110-116. 

Van Rijswick, M.H.J., 1978, in Hydrides for Energy Storage, eds A.F. Andresen and A.J. Maeland (Pergamon Press, Oxford) pp. 261-271. Venkatesan, S., and B. Reichman, 1989, in Proc. 24th Intersociety Energy Conversion Engineering Conference, Crystal City, p. 1665. 

Vbnkatesan, S., M.A. Fetcenko and B. Reichman, 1989, in Proc. 24th Intetsociety Energy Conversion Engineering Conference, Crystal City, p. 1659. 

Engineering Workshop, Crystal City, Virginia, November, 1988... 

The U.S. Patent and Trademark Office is located in Crystal City, VA, and more importantly on the Internet as USPTO.com. It offers an extensive database, which can be accessed easily. One can search by inventors, assignees, titles, keywords, patent classes, etc. It is updated every Tuesday. 

---