James V. McArdle, PhD

James V. McArdle, PhD, is the vice-president of analytical development and quality for Isis Pharmaceuticals, Inc., 2292 Faraday Ave., Carlsbad, CA 92008, tel. 760.931.9200, fax 760.603.4655.

Articles

Investigation of Out-of-Specification Results

January 01, 2002

The authors summarize the results of the September 2000 PhRMA workshop discussions about conducting out-of-specification investigations.