Advisory Committee for Pharmaceutical Science

Meeting May 7 - 8, 2002

Bibliography

Day 1: May 7

Biopharmaceutical Classification System

Amidon, Gordon, H. Lennernas, V Shah, and J Crison. A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharmaceutical Research 12:413-420. 1995.

Yu, Lawrence, et al. Biophramaceutics Classification System: The scientific basis for biowaiver extensions. Submitted to Pharmaceutical Research. March 19, 2001.

Yu, Lawrence, et al. Influence of drug release properties of conventional solid dosage forms on the systemic exposure of highly soluble drugs. AAPS PharmSci. 3(3) article 24. September 8, 2001.

Day 2: May 8

Rapid Microbial Testing

Lewandoski, N. Is there time for rapid micro? Pharmaceutical Formulation and Quality. April/May 2001. pp. 17-22.

Reynolds, D. T. and C. R. Fricker. Application of laser scanning for the rapid and automated detection of bacteria in water samples. J. Appl. Micro. Vol. 86 pp. 785-795. 1999.

Wallner, G. et al. The ChemScan system:a new method for rapid microbiological testing of water. European Journal of Parenteral Science. Vol 2 No. 4 pp. 123-126. 1997.

Boehm, Garth et. al. Results of statistical analysis of blend and dosage unit content uniformity data obtained from the Product Quality Research Institute Blend Uniformity Working Group data-mining effort. Unpublished. March 2002.

PQRI Blend Uniformity Working Group. The use of stratified sampling of blend and dosage units to demonstrate adequacy of mix for powder blends. Unpublished. March 2002.

Regulatory Issues - Polymorphism

Decision Tree #4: Investigating the need to set acceptance criteria for polymorphism in drug substances and drug products. in ICH Q6A page 83055