The authors wish to thank Fasheng Li, associate director of statistics–Groton at Pfizer (New York) for creating the plots
used in the paper. Thank you to Tom Garcia, a research fellow for global regulatory CMC–Groton at Pfizer and Ambarish Singh,
associate director of global regulatory sciences–CMC at Bristol-Myers Squibb (New York) for reviewing the paper.
James Bergum* is an associate director of nonclinical biostatistics at Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903,
tel. 732.227.5981, fax 732.227.3005, email@example.com
. Kim Erland Vukovinsky is a director of nonclinical statistics at Pfizer.
*To whom all correspondence should be addressed.
Submitted: Mar. 15, 2010. Accepted: Apr. 12, 2010.
1. USP 33–NF 28 Reissue, General Chapter <905>, "Uniformity of Dosage Units," (US Pharmacopeial Convention, Rockville, MD, Oct. 2010,
2. D. Sandell, et al., Drug Info. J., 40, 337–344 (2006).