Bibliography
Advisory Committee for Pharmaceutical Science
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
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
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.
Product Design and Pharmaceutical
Equivalence
1.
Polli, James,