Advisory Committee for Pharmaceutical Science

May 3-4, 2005



Day 1: Tuesday, May 3, 2005



Establishing Drug Release or Dissolution Specifications


1.      Woodcock, Janet, "The Concept of Pharmaceutical Quality", American Pharmaceutical Review, November/December 2004.


2.      Hussain, Ajaz, "Process Analytical Technology: A First Step in a Journey Towards the Desired State", Journal of Process Analytical Technology, January/February 2005.


3.      ICH Draft Consensus Guideline Pharmaceutical Development Q8,
http://www.ich.jorg/MediaServer.jser?@ ID=1707&@ Mode=GLB


4.      Sathe, Pradeep M., Raw, Andre S, et. al., "Drug Product Performance: In-Vitro", Chapter 8, Generic Drug Product Development: Solid Oral Dosage Forms. Marcel Dekker Publisher, (2005): 187-209.

5.      Subcommittee on Dissolution Calibration, Pharmaceutical Research and Manufacturers Association (PhRMA), "Dissolution Calibration: Recommendations for Reduced Chemical Testing and Enhanced Mechanical Calibration", Pharmacopeial Forum, vol.26, no.4, (2000): 1149-1166.

6.      Kukura, J., Baxter, J.L., Muzzio, F.J., " Shear Distribution and Variability in the USP Apparatus 2 Under Turbulent Conditions, International Journal of Pharmaceutics, Vol. 279, (2004): 9-17.

7.      Quereshi, Saeed A. and Shabnam, Javad, " Cause of High Variability in Drug Dissolution Testing and Its Impact on Setting Tolerances", European Journal of Pharmaceutical Sciences, Vol. 12 (2001): 271-276.

8.      Torbeck, Lynn D., "In Defense of USP Singlet Testing", Pharmaceutical Technology, February 2005. pages 105-106.

9.      Hofer, Jeffrey D. and Gray, Vivian A., "Examination of Selection of Immediate Release Dissolution Acceptance Criteria", Dissolution Technologies, February 2003, pages 16-20.

10. Kaniwa, Nahoko, "Japanese Perspectives on Pharmaceutical Product Release Rate Testing", Drug Information Journal, Vol. 36 (2002): 407-415.


Day 2: Wednesday, May 4, 2005


Product Design and Pharmaceutical Equivalence


1.      Polli, James, Yu, Lawrence, et. al., "Summary Workshop Report: Biopharmaceutics Classification System -- Implementation Challenges and Extension Opportunities", Journal of Pharmceutical Sciences, Vol. 93 (2004): 1375-1381.