Science & Research
Volume IV - 3.5 References
Orientation and Training
|VERSION NO.: 1.7|
Section 3 - Drug Analysis
|EFFECTIVE DATE: 10-01-03||REVISED: 02-14-13|
- A brief legislative history of the food, drug, and cosmetic
History of FDA http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm
- 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
- Federal Food, Drug, and Cosmetic Act, Washington, DC: U.S. Government Printing Office or http://www.fda.gov/RegulatoryInformation/Legislation/default.htm
- Requirements of laws and regulations enforced by the U.S. Food and Drug Administration http://www.fda.gov/RegulatoryInformation/Legislation/default.htm
- U.S. Food & Drug Administration, Office of Regulatory Affairs, Office of Enforcement. Investigations operations manual.
- 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)
- 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.
- U. S. Food and Drug Administration, Office of Regulatory Affairs, Regulatory Procedures Manual, http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm
- United States Pharmacopeia and National Formulary (current ed.). Gaithersburg, MD:
- Official Methods of Analysis of AOAC International, AOAC International, (current ed.). Gaithersburg MD: Chapters18 through 22
- Remington's pharmaceutical sciences (current ed.). Easton, PA: Mack Publishing Company.
- Banes, D. (1966). Principles of regulatory drug analysis (chap. 1). Arlington, VA: Association of Official Analytical Chemists.
- Banes, D. (1974). A chemist's guide to regulatory drug analysis (Pt.1). Arlington, VA: Association of Official Analytical Chemists.
- Chatten, L. G. (1969). Pharmaceutical chemistry (Vol. 1, pp. 66-67; Vol. 2, pp. 62-125). New York: Marcel Dekker.
- Nilsen, C. L. (1998). The QC laboratory chemist: plain and simple. Buffalo Grove, IL: Interpharm Press, Inc.
- Gringauz, A. (1997). Introduction to medicinal chemistry, how drugs act and why. New York: Wiley-VCH.
- Ansel, H. C., Allen, L.V., Popovich, N. G. (1999). Pharmaceutical dosage forms and drug delivery systems (7th ed.). Philadelphia: Lippincott, Williams & Wilkins.
- Fowlis, I. A. (1995). Gas chromatography, analytical chemistry by open learning (2nd ed.). New York: John Wiley & Sons. or other version
- Linsay, S. (1987). High performance liquid chromatography, analytical chemistry by open learning. New York: John Wiley & Sons. or other version
- U.S. Food & Drug Administration/Center for Drug Evaluation and Research, National Center for Drug Analysis audio-visual series, “Dissolution Analysis.”
- Denny, R. C., Sinclair, R. (1987). Visible and ultraviolet spectroscopy, analytical chemistry by open learning. New York: John Wiley & Sons. or other version
- Snyder and Kirkland (1979). Introduction to modern liquid chromatography (2nd ed.) New York: Wiley Interscience.
- Wilson, C. O. et al. (2004). Wilson& Gsivold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry
- Rouessac and Rouessace (2000) Chemical Analysis :Modern Instrumentation Methods and Techniques.
- George, B., McIntyre, P. (1987). Infrared spectroscopy analytical chemistry by open learning. New York: John Wiley & Sons.
- Moffat, Anthony C et al, 2004, Clarke’s Analysis of Drug and Poisons, Third Edition, 2 volume set
- Ahuja, S., and Scypinski, 2001, Handbook of Modern Pharmaceutical
Analysis, Academic Press San Diego CA
- The Merck Index, An Encyclopedia of Chemicals, Drugs, and Biologicals, Merck & Co., Inc., Whitehouse Station, NJ. (most recent edition).