BioPharm International-05-01-2003

by Robert J. Seely, Amgen, Inc. Louis Munyakazi, John Haury, Heather Simmerman, W. Heath Rushing, and Thomas F. Curry Determining whether a data point is an "outlier" ? a result that doesn't fit, that is too high or too low, that is extreme or discordant ? is difficult when using small data sets (such as the data from three, four, or five conformance runs). The authors show that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.

by Lorna D. McLeod, BioPharm International

by Craig R. Kaufman, Orrick, Herrington & Sutcliffe LLP, Rebecca Burton, and Anne-Marie Dinius Your patent portfolio does not make money sitting in a file cabinet. Extracting its value requires both market surveillance and an effective litigation or licensing strategy.

by James D. Williams, Virginia Polytechnic Institute and State University, Jeffrey B. Birch, and Steven Walfish Statistics don't lie, but if you don't include appropriate data, the resulting statistical analyses can be misleading. In biopharmaceutical development, if the variability from several different microplates is not addressed, assays testing the relative potency against a standard can be inaccurate. A statistical method that accounts for plate-to-plate heterogeneity is needed ? and presented here.

by Jill Wechsler, BioPharm International FDA proposes bar codes on drug packages and new error reporting standards as part of its campaign to reduce medication errors.

by Wolfgang Winter, Agilent Technologies GmbH and Ludwig Huber, Agilent Technologies GmbH The rules for electronic records and signatures still remain in effect. The change means that companies must now justify their decisions on whether or not to implement specific electronic controls with documented risk assessments and considerations of the record requirements detailed in the corresponding predicate rule.

by Susan McLaughlin, Drug Information Association The Drug Information Association unveils the first in a series of professional development programs delivered through eLearning technologies to members worldwide.

by Sean Sales, RTS Life Science International RTS Life Science International works with clients to develop modular system.