U.S. Food and Drug Administration • Center for Drug Evaluation and ResearchSkip navigation
CDER - Center for Drug Evaluation and Research Logo

Office of Pharmaceutical Science

CDER Home Site Information Comments and Feedback What's New CDER Navigation Bar

CDER ArchivesSpecific AudiencesCDER CalendarRegulatory InformationDrug InformationAbout CDERSide Navigational Buttons

Process Analytical Technology 
(PAT) Initiative Journal Club

The Journal Club discusses articles and research relating to the implementation and development of systems and methods for PAT applications.

Articles for discussion:

April, 2003

  • Advances in pharmaceutical materials and processing. Morris, K. R., Nail, S. L., Peck, G. E., Byrn, S. R., Griesser, U. J., Sotwell, J. G., Hwang, S-J, and Park, K. Pharmaceutical Science and Technology Today. 1 (6):235-245 (Sept. 1998).

  • Accelerated fluid-bed drying using NIR monitoring and phenomenological modeling. Morris, K. R., Stowell, J. G., Byrn, S. R., Placette, A. W., Davis, T. D., and Peck, G. E. Drug Development and Industrial Pharmacy. 26 (9):985-988 (2000).
  • Determination of average crystallite shape by X-ray diffraction and computational methods. Morris, K. R., Schlam, R.F., Cao, W., and Short, M. S. Journal of Pharmaceutical Sciences. 89 (11):1432-1442 (2000). Published online Journal of Pharmaceutical Sciences (15 September 2000).
  • Modeling of powder blending using on-line near-infrared measurements. Ufret, C. and Morris, K. R. Drug Development and Industrial Pharmacy. 27 (7): 719-729 (2001).
  • Technical Note: Development and validation of a near infrared method for the analytical control of a pharmaceutical preparation in three steps of the manufacturing process.  M. Blanco, J. Coello, H. Iturriaga, S. Maspoch, N. Pou Fresenius' Journal of Analytical Chemistry Abstract Volume 368 Issue 5 (2000) pp 534-539.
  • Rapid quantification of constituents in St. John's wort extracts by NIR spectroscopy.  I. Rager, G. Roos, P. C. Schmidt and K. A. Kovar Journal of Pharmaceutical and Biomedical Analysis Volume 28, Issues 3-4 , 15 May 2002, Pages 439-446.
  • One hundred percent online identity check of pharmaceutical products by near-infrared spectroscopy on the packaging line Thorsten Herkerta, Heino Prinzb and Karl-Artur Kovar European Journal of Pharmaceutics and Biopharmaceutics Volume 51, Issue 1 , January 2001, Pages 9-16.
  • Spectroscopic Approach for On-Line Monitoring of Particle Size During the Processing of Pharmaceutical Nanoparticles. JP Higgins, et al. Anal. Chem. 75: 1777-1785 (2003).
  • Multivariate calibration: applications to pharmaceutical analysis. M. Forinaa, M. C. Casolinoa and C. de la Pezuela Martinez. Journal of Pharmaceutical and Biomedical Analysis Volume 18, Issues 1-2 , October 1998, Pages 21-33.
  • The use of experimental design methodology and multivariate analysis to determine critical control points in a process, NS Sahni, et al. Chemometrics and Intelligent Lab Sys. 56 105-121 (2001).
  • PLS-regression: a basic tool of chemometrics. S. Wold, et al. Chemometrics and Intelligent Lab Sys. 58 109-130 (2001).

February, 2003

  • Chemometric analysis of Raman spectroscopic data for process control applications.  Cooper, J.B., Chemometrics and Intelligent Laboratory Systems 46: 231-247, 1999.
  • Guidelines for the development and validation of near-infrared spectroscopic methods in the pharmaceutical industry. Broad, N., et al.  In Handbook of Vibrational Spectroscopy, eds. Chalmers, J.M. and Griffiths, P.R., Pharmaceutical Analytical Sciences Group, NIR Sub-Group, UK,: John Wiley and Sons, Ltd., 2002.
  • ASTM Standard Practice D 6299: "Standard practice for applying statistical quality assurance techniques to evaluate analytical measurement system performance."
  • ASTM Standard Practice D 3764: "Standard practice for validation of process stream analyzers."

totop.gif (1525 bytes) Back to Top   Back Back to PAT

FDA/Center for Drug Evaluation and Research
Created: February 5, 2003, Last Updated: April 23, 2003
Originator: OTCOM/OPS
HTML by SJW