H. Winkle

Quality by design for biopharmaceuticals

A. Rathore, H. Winkle, 2009, Nature Biotechnology.

Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond

Jack A. Cook, Vinod P. Shah, Lawrence X. Yu, 2008, The AAPS Journal.

The FDA's assessment of follow-on protein products: a historical perspective

Steven Kozlowski, Janet Woodcock, Christopher Joneckis, 2007, Nature Reviews Drug Discovery.

Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report.

Lawrence X. Yu, H. Winkle, S. Preskorn, 2010, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report.

Lawrence X. Yu, H. Winkle, S. Preskorn, 2010, Clinical therapeutics.

Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products: Workshop Summary Report

Lawrence X. Yu, H. Winkle, S. Preskorn, 2010, The AAPS Journal.