Useful Links

Click on any of the links below to access websites of various Health Authorities, Pharmaceutical Trade Associations and important regulatory guidelines.

Health Authorities, Government and Trade Organizations

Food and Drug Administration (USA)
US Pharmacopeia (USP)
World Health Organization (WHO)
European Heads of Agencies
European Medicines Agency (EMEA)
Health Canada
Drug Information Association (DIA)
European Commission Pharmaceuticals Directorate (F2)
European Directorate for the Quality of Medicinces (EDQM)
European Federation of Pharmaceutical Industries and Associations
Pharmaceutical Research and Manufacturers of America (PhRMA)
US Generic Pharmaceutical Association (GPhA)


Regulatory guidelines

ICH Harmonized Tripartite Guideline Q3A(R), Impurities in New Drug Substances
ICH Harmonized Tripartite Guideline Q3B(R), Impurities in New Drug Products
ICH Harmonized Tripartite Guideline Q3C(M), Impurities:Residual Solvent Tetrahydrofuran
ICH Harmonized Tripartite Guideline Q3C(M), Impurities:Residual Solvent N-Methylpyrrolidone
ICH Harmonized Tripartite Guideline Q3C, Impurities: Guideline for Residual Solvents
ICH Guideline on Stability Testing of drugs and drug products.
ICH Guidance for Industry Q7A, Good Manufacturing Practise Guidance for Active Pharmaceutical Ingredients.
ICH Guidance for Industry, Investigating Out-of-Specification (OOS).


PUBLICATIONS

  1. P. Kucera, "A Study of Low Molecular Compounds by Continuous Gel Filtration", 1967, Technical University, Prague, (M.S. Diploma Thesis). .
  2. P. Kucera, R. Scott, K. Chan and S. Zolty, "The Use of Resin Coated Glass Beads for Solid Phase Synthesis of Peptides", J. Chromatogr. Sci., 9, 641, 1971.
  3. R. Scott, P. Kucera, "The Design of Column Connection Tubes for LC", J. Chromatogr. Sci., 9, 641, 1971.
  4. R. Scott, P. Kucera, "Some Aspects of Liquid-Solid Vacancy Chromatography", Anal. Chem., 44, 100, 1972.
  5. R. Scott, P. Kucera, "The Examination of Some Silica Gels", J. Chromatogr., Sci., 12,473, 1974.
  6. R. Scott, P. Kucera, "A Rational Series of Solvents for Use in Incremental Gradient Elution", Anal. Chem., 45, 749, 1973.
  7. R. Scott, P. Kucera, "An Apparatus for Use with Incremental Gradient Elution", J. Chromatogr., Sci., 11, 83, 1973.
  8. R. Scott, P. Kucera, "Incremental Gradient Elution Development in Liquid-Solid Chromatography", J. Chromatogr., 80, 295, 1973.
  9. R. Scott, P. Kucera, "Solute Interactions with the Mobile Phase and Stationary Phases In Liquid-Solid Chromatography", J. Chromatogr. Sci., 112, 425, 1975.
  10. R. Scott, P. Kucera, "Some Aspects of the Chromatographic Properties of Thermally Modified Silica Gels", J. Chromatogr. Sci., 13.337, 1975.
  11. R. Scott, P. Kucera, "Some Aspects of Preparative Scale-Liquid Chromatography", J. Chromatogr.", 119, 467, 1976.
  12. R. Scott, P. Kucera, "The Examination of Five Reverse Phases", J. Chromatogr., 142, 213, 1977.
  13. R. Scott, P. Kucera, "Solute/Solvent Interactions on the Surface of Silica Gel", J. Chromatogr., 149, 93, 1978.
  14. P. Kucera, R. Scott and M. Munroe, "Rapid Chromatographic Separations Using Microbore Columns", J. Chromatogr., 169, 475, 1979.
  15. R. Scott, P. Kucera, " Mode of Operation and Performance Characteristics of Microbore Columns", J. Chromatogr., 169, 51, 1979.
  16. R. Scott, P. Kucera, "The Exclusion Properties of Some Silica Gels", J. Chromatogr., 125, 251, 1976.
  17. R. Scott, P. Kucera, "The Use of Microbore Columns for Separation of Substances of Biological Origin", J. Chromatogr., 185, 27, 1979.
  18. R. Scott, P. Kucera, "Solute-Solvent Interactions on the Surface of Silica Gel-- Part II", J. Chromatogr., 171, 37, 1979.
  19. R. Scott, P. Kucera, "Some Aspects of Ion-Exchange Liquid Chromatography on Reverse Phase Columns", J. Chromatogr., 175, 51, 1979.
  20. P. Kucera, "Dynamic Solvent Generated Ion-Exchange Liquid Chromatography", Rutgers University, 1980, Ph.D. Diploma Thesis.
  21. P. Kucera, "The Design and Use of Short Microbore Columns In Liquid Chromatography", J. Chromatogr., 198, 93, 1980.
  22. P. Kucera, G. Manius and A. Mlodozeniec, "Differential Frontal Analysis of Carboxylic Acid", J. Chromatogr., 210, 373, 1981.
  23. P. Kucera, G. Manius, "High-Resolution Reverse Phase LC Utilizing Microbore Column Concatenation", J. Chromatogr., 216, 9, 1981.
  24. P. Kucera, G. Manius, "Recycling LC Using Microbore Columns", J. Chromatogr., 219, 1, 1981.
  25. P. Kucera, H. Umagat, L. Wen, "Total Amino Acid Analysis Using Pre-Column Fluorescence Derivatization", J. Chromatogr., 239, 463, 1982.
  26. P. Kucera, H. Umagat, "Design of a Post-Column Fluorescence Derivatization System", J. Chromatogr., 255, 563, 1983.
  27. P. Kucera, H. Schwartz and B. Karger, "Gradient Elution with Microbore Columns", Anal. Chem., 55, 1752, 1983.
  28. P. Kucera, G. Guiochon, "Use of Open-Tubular Columns in Liquid Chromatography", J. Chromatogr., 283, 1, 1984.
  29. P. Kucera, Book on "Microcolumn High-Performance liquid Chromatography", 300 pages, Journal of Chromatography Library Volume No. 28, Elsevier Scientific Publishing Co., New York, 1984.
  30. P. Kucera, J. Lepore, "Computer Modeling of Chromatographic Processes", Chromatography, Vol, 2, Number 3, April 1987.
  31. P. Kucera, N. Licato, "High-Speed Liquid Chromatography Using Small Particles Diameter Columns", Book By Marcell Dekker, 1991, New York.

P.O. Box 07194
Fort Myers, Florida 33919, USA
phone: +1 (845) 545-0767
email: pkucera1000@yahoo.com