Food and Drug Administration (FDA)
St. Louis Pharmaceutical Laboratory
from 1967-1994
The Executive Summaries of the St. Louis FDA laboratory are public domain; they were distributed to visitors and other individuals interested in the laboratory's activities. All other materials were submitted for publication or presented in public meetings and forums.
Division Mission Statement
- To help ensure, through physical and chemical assessments, the safety and efficacy of human drugs used in the United States;
- To provide a strong scientific and analytical base to support complex FDA investigations of human drugs;
- To provide leadership and support to advancing new research programs to assess human drugs;
- To conduct excellent science and research in support of human drug programs; and
- To be recognized as one of the finest regulatory pharmaceutical laboratories in the world.
Executive Summaries
Selected Publications and Reports
- Quality Assurance in an FDA Laboratory, originally presented by Mr. Ross D. Kirchhoefer in 1979 at the “ASQC Technical Conference” in Houston, Texas.
- System Suitability Tests in Regulatory Liquid and Gas Chromatographic Methods: Adjustments Versus Modifications, William B. Furman, John G. Dorsey, and Lloyd R. Snyder. Originally published in the June, 1998 issue of Pharmaceutical Technology.
- The Food and Drug Administration's Testing Centers, Daniel Banes, 1968.
- Problems and Solutions Relating to the Regulatory Use of Automated Equipment, by Richard F. Heuermann, 1970.
- Interview with Dr. Arthur W. Steers and Mr. Richard F. Heuermann, Director and Deputy Director of the National Center for Drug Analysis, St. Louis Missouri. 1970.
- FDA's Drug Monitoring Program for the 70s, Arthur W. Steers, Ph.D
- Computer assisted automated drug analysis, by Prince Eugene Bosley, this article was submitted to and appeared in American Laboratory 6(9), 27-29 (1974).
- A Safety Cap for Drugs, St. Louis Globe Democrat, Feb. 11, 1984.
- Space-Age World of FDA's Drug Analysis Center, FDA Today, vol 7, No. 11, page 8
- An FDA Laboratory Approach to Uncovering Potential Fraud in the Generic Drug Industry, Ross D. Kirchhoefer, submitted to and appeared in, Journal of AOAC International, 75, 1992, 577.
- Selection and Validation of Legal Reference Methods of Analysis for Pharmaceutical Products in the U.S.A., by Thomas Layloff and Paul Motise, Pharmaceutical Technology, September 1992, pp 122-132.
- Validation of Computerized Liquid Chromatographic Systems, W. B. Furman, T. Layloff, and R. F. Tetzlaff , submitted to and appeared in, J. AOAC Int., 1994, 77, 1314-1318.
- Weighing on an Analytical Balance, A. S. Kenyon and T. P. Layloff , Pharmacopeial Forum, 22 (4),1996
- REVIEW OF 73 Consecutive NDA-Method Validation Package EVALUATIONS, 1997
- System Suitablility Tests in Regulatory Liquid and Gas Chromatographic Methods: Adjustment vs. Modification, William B. Furman, John G. Dorsey, Lloyd R. Snyder, Pharmaceutical Technology, June 1998, 58-64.
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