Food and Drug Administration (FDA)
St. Louis Pharmaceutical Laboratory
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.
Selected Publications and Reports
- 1997 Survey of 73 Consecutive New Drug Application-Method Validation Packages (NDA-MVP) Submitted to FDA for Validation
- 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.
- 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.
- REVIEW OF 73 Consecutive NDA-Method Validation Package EVALUATIONS, 1997
- Weighing on an Analytical Balance, A. S. Kenyon and T. P. Layloff , Pharmacopeial Forum, 22 (4),1996
- 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.
- 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.
- 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.
- Analytical Methods for Pharmaceutical Analysis: A Training Manual ,A. S. Kenyon, R. D. Kirchhofer, and T. P.Layloff, 1992.
- Analyst Training and Certification Program, by Carol M. Kerner1992
- Training Modules to Develop Analytical Proficiency for Pharmaceutical Chemists, by Allen S. Kenyon, Ross D. Kirchhoefer, and Thomas P. Layloff, Reprinted from Journal of AOAC International Vol. 75, No. 4, 1992.
- 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.
- Quality Assurance in an FDA Laboratory, originally presented by Mr. Ross D. Kirchhoefer in 1979 at the “ASQC Technical Conference” in Houston, Texas.
- Computer assisted automated drug analysis, by Prince Eugene Bosley, this article was submitted to and appeared in American Laboratory 6(9), 27-29 (1974).
- 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
- The Food and Drug Administration's Testing Centers, Daniel Banes, 1968.
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