Références
DES industrie
Validation
Sites Webs
Organismes
Références
Documents
  1. Guideline for submitting samples and analytical data for methods validation. Food and Drug Administration, February 1987. US Government Printing Offfice:1990-281-794:20818.
  2. Reviewer guidance, validation of chromatographic methods. Center for Drug Evaluation and Research, FDA, 1994
  3. U.S. Pharmacopeia 23, pp. 1982-1984, 1776-7. U.S. Pharmacopeia Convention, 1995.
  4. Layloff, T. and Motise, P. Selection and validation of legal reference methods of analysis for pharmaceutical products in the U.S. Pharmaceutical Technology, pp. 122-132, September 1992
  5. Furman, W. B., Layloff, T. P. and Tetzlaff, R. F., Validation of computerized liquid chromatographic systems. J. AOAC Int., Vol 77 (#5), pp. 1314-1318, 1994.
  6. Paul, W. L., USP perspectives on analytical methods validation. Pharmaceutical Technology, pp. 130-141, March 1991
  7. Bopp., R. J., Wozniak, T. J., Anliker, S. L. and Palmer, J. Development and validation of liquid chromatographic assays for the regulatory control of pharmaceuticals. Chapter 10, pp. 315-344 in Pharmaceutical and Biomedical Applications of Liquid Chromatography, Riley, C.M., Lough, W. J and Wainer, I. W., Editors. Elsevier (Pergamon), 1994.
  8. Karnes, H. T., Shiu, G. and Shah, V. P. Validation of bioanalytical methods. Pharmaceutical Research, Vol. 8 (#4), pp. 421-6, 1991
  9. International Conference on Harmonization. Draft guideline on validation of analytical procedures: definitions and terminology. Federal Register, Vol. 60, pp. 11260, March 1, 1995.
  10. Proceedings from the Third International Conference on Harmonization, Yokohama, Japan, December, 1995.
  11. FDA’s policy statement for the development of new stereoisomeric Drugs. Chirality, Vol. 4, pp. 338-340, 1992
  12. Virlichie, J. L. and Ayache, A. A ruggedness test and its application for HPLC validation. S. T. P. Pharma Pratiques, Vol 5(1), pp. 49-60, 1995.
  13. Swartz, M. E. Method development and selectivity control for small molecule pharmaceutical separations by CE. J. Liq. Chrom., Vol. 14, pp 923, 1991.
  14. Swartz, M. E., Mazzeo, J. R., Grover, E. R. and Brown, P. R. Validation of enantiomeric separations by micellar electrokinetic capillary chromatography using synthetic chiral surfactants. J. Chrom. A, Vol 735, pp. 303-310, 1996.
  15. Green, M. J., A practical guide to analytical method validation. Anal. Chem. News and Features, May 1, 1996, pp. 305-309A
  16. Development and Validation of Analytical Methods, Progress in Pharmaceutical and Biomedical Analysis Volume 3, Edited by C. M. Riley and T. W. Rosanske, Pergamon/Elsevier, Tarrytown, NY. USA, 1996.
  17. Maxwell, W. and Sweeney, J., Applying the validation timeline to HPLC system validation. LC/GC, Volume 12(9), September 1994, pg. 678-82.
  18. Swartz, Me. E. and Krull, I. S., Analaytical Method Development and Validation, Marcel Dekker, Inc. NY, USA, 1997.

Toute remarque concernant ce site peut être envoyée à
Jean Cumps - Faculé de Médecine UCL - Ecole de Pharmacie - TPAO

Dernière modification : vendredi, 30 mai, 2003