References

1. International Conference on Harmonization: Guideline on Validation of Analytical Procedures: Definitions and Terminology Avaliability, Fed. Reg., 60, 11260-2 (1995)

2. M.P. Newton, J. Mascho, R.J. Maddox, ACS Symposium Series 512, 41-53 (1992)

3. Jeri May, DuPont Merck Pharmaceutical Company, personal communications (1995)

4. A.E. Greenberg, L.S. Clesori and A.D. Eaton. Standard Methods for the Examination of Water and Wastewater, 18th ed. American Public Health Association, Washington, DC (1992)

5. R. Bopp, "Analytical Technology Relevant to Stereoisomerism", AAPS Workshop on Impurities in Drug Substance and Products, April 3-4, Arlington, VA (1995)

6. W. Linder, C. Petterson in "Liquid Chromatography in Pharmaceutical Development: An Introduction", I.W. Wainer (ed.), Aster, Springfield, OR, 63-131 (1985)

7. E. Debesis, J. Boehlert, T. Givand and J. Sheridan Pharm. Tech Sept., p. 120-137 (1982)

8. PMA (Analytical R&D Subsection and Pharmaceutical R&D subsection) meeting Washington, DC, April 10-12, 1994

9. J.C. Wahlich and G.P. Carr, J. Pharm. Biomed. Anal., 8, , 619-623 (1990)

10. PMA Workshop on Reference Standards, sponsored by the PMA Analytical Steering Committee, Washington DC, 1992

FDA Guidelines for Supporting Documentation in Drug Applications for the Manufacture of Drug Substances, February 1987

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