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Volume IV - 3.5 References

DFS Pyramid Logo

Orientation and Training

Food and Drug Administration

DOCUMENT NO.:

IV-03
VERSION NO.: 1.7

Section 3 - Drug Analysis

EFFECTIVE DATE: 10-01-03REVISED: 02-14-13
  1. A brief legislative history of the food, drug, and cosmetic
    History of FDA http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm 
  2. Code of Federal Regulations Title 21, Pts. 31, 200-499; Pts. 210-Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs In General and Pt. 211-Current Good Manufacturing Practice for Finished Pharmaceuticals. Washington, DC: U.S. Government Printing Office. or http://www.fda.gov/RegulatoryInformation/Legislation/default.htm 
  3. Federal Food, Drug, and Cosmetic Act, Washington, DC: U.S. Government Printing Office or  http://www.fda.gov/RegulatoryInformation/Legislation/default.htm
  4. Requirements of laws and regulations enforced by the U.S. Food and Drug Administration http://www.fda.gov/RegulatoryInformation/Legislation/default.htm
  5. U.S. Food & Drug Administration, Office of Regulatory Affairs, Office of Enforcement. Investigations operations manual
    http://www.fda.gov/ICECI/Inspections/IOM/default.htm
  6. U. S. Food and Drug Administration, Office of Regulatory Affairs, Office of Enforcement. Compliance policy guides, http://www.fda.gov/ICECI/ComplianceManuals/default.htm    (compliance references)
  7. U. S. Food and Drug Administration, Office of Regulatory Affairs, Center for Drug Evaluation and Research. Compliance Program Guidance Manual, Sections 46, 52, and 56.
  8. U. S. Food and Drug Administration, Office of Regulatory Affairs, Regulatory Procedures  Manual,  http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm
  9. United States Pharmacopeia and National Formulary (current ed.).  Gaithersburg, MD: 
  10. Official Methods of Analysis of AOAC International, AOAC International, (current ed.). Gaithersburg  MD:   Chapters18 through 22 
  11. Remington's pharmaceutical sciences (current ed.). Easton, PA:  Mack Publishing Company. 
  12. Banes, D. (1966). Principles of regulatory drug analysis (chap. 1). Arlington, VA:  Association of Official Analytical Chemists.  
  13. Banes, D. (1974). A chemist's guide to regulatory drug analysis (Pt.1).  Arlington, VA: Association of Official Analytical Chemists.  
  14. Chatten, L. G. (1969). Pharmaceutical chemistry (Vol. 1, pp. 66-67; Vol. 2,  pp. 62-125). New York: Marcel Dekker. 
  15. Nilsen, C. L. (1998). The QC laboratory chemist: plain and simple. Buffalo Grove, IL: Interpharm Press, Inc.
  16. Gringauz, A. (1997). Introduction to medicinal chemistry, how drugs act and why. New York: Wiley-VCH.
  17. Ansel, H. C., Allen, L.V., Popovich, N. G. (1999). Pharmaceutical dosage forms and drug delivery systems (7th ed.). Philadelphia:  Lippincott, Williams & Wilkins. 
  18. Fowlis, I. A. (1995). Gas chromatography, analytical chemistry by open learning (2nd ed.).  New York: John Wiley & Sons. or other version 
  19. Linsay, S. (1987). High performance liquid chromatography, analytical chemistry by open learning.  New York: John Wiley & Sons. or other version
  20. U.S. Food & Drug Administration/Center for Drug Evaluation and Research, National Center for Drug Analysis audio-visual series, “Dissolution Analysis.” 
  21. Denny, R. C., Sinclair, R. (1987). Visible and ultraviolet spectroscopy, analytical chemistry by open learning.  New York: John Wiley & Sons. or other version
  22. Snyder and Kirkland (1979). Introduction to modern liquid chromatography (2nd ed.) New York:  Wiley Interscience. 
  23. Wilson, C. O. et al. (2004). Wilson& Gsivold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry 
  24. Rouessac and Rouessace (2000) Chemical Analysis :Modern Instrumentation  Methods and Techniques.  
  25. George, B., McIntyre, P. (1987). Infrared spectroscopy analytical chemistry by open   learning. New York: John Wiley & Sons.  
  26. Moffat, Anthony C et al, 2004, Clarke’s Analysis of Drug and Poisons, Third Edition,  2 volume set
  27. Ahuja, S., and Scypinski, 2001, Handbook of Modern Pharmaceutical 
    Analysis, Academic Press San Diego CA
  28. The Merck Index, An Encyclopedia of Chemicals, Drugs, and Biologicals, Merck & Co., Inc.,  Whitehouse Station, NJ.  (most recent edition).