BOOKS

RECENT PUBLICATIONS AND PRESENTATIONS

Chen M-L, Shah VP, Crommelin DJ, Shargel L, et al: Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: Workshop summary report, European Journal of Pharmaceutical Sciences 44:506–513, 2011and AAPS Journal, 13:556-564, 2011

Shargel L: International Reference Listed Drug Product, presented in roundtable discussion Bioequivalence Requirements: Challenges in Global Drug Development and Harmonization, American Association of Pharmaceutical Scientists, Annual Meeting, Los Angeles, CA, November 2009

Shargel L: Drug Product Performance and Interchangeability of Multisource Drug Substances and Drug Products, Pharmacopeial Forum, 35(3), 744-799, 2009

Shargel L: Drug Product Performance In Vivo- Assessment of Bioavailability & Challenges in the Demonstration of Bioequivalence, University of Concepcion, Concepcion, Chile, October 2009

Shargel L: Use of an International Reference Listed Drug Product, RLD as a Standard, Identify the Problem, Bio-International 2008, London, UK, October, 2008

Shargel L: Challenges in the Development of Generic Drug Products, Eino Nelson Conference, Coral Gables, FL, March 2006

Shargel L, Foster T: USP advisory panels on the USP performance test, Pharmacopeial Forum, 31(6), 1742-1744, 2005