The authors, Richard Kissel, Matthew Scholl, Steven Skolochenko and Xing Li wish to express their thanks to colleagues who reviewed the drafts of this document and everyone who provided comments. In particular, their appreciation goes Rick Ayers, Murugiah Souppaya, Mark Wilson, Tanya Brewer and Elizabeth Lennon who assisted with our internal review process. Thanks also goes to William Gill, Dr. Chun Tse, and Dr. Simson Garfinkel for their research, technical support, and written contributions to this document. Thanks also to Kevin Stine of the FDA for his keen insights and assistance with the final review. This work.
