Pengarang: Mark F. Vitha

BERNARD A. OLSEN, Ph D, has close to three decades of experience at Eli Lilly and Company in chemistry, manufacturing, and control of drug substances and drug products. He contributed to the development and support of more than twenty-five commercialized drugs as well as numerous developmental drugs. A Fellow of the American Association of Pharmaceutical Scientists, Dr. Olsen currently provides consulting and training services to the pharmaceutical industry and serves as Chair of the USP Expert Committee on Monograph Development: Small Molecules 3. BRIAN W. PACK, Ph D, is a Research Advisor in Analytical Sciences R&D at Eli Lilly and Company, where he has contributed to the development of many solid oral and parenteral dosage forms. He is recognized for his contributions to HPLC method development, raw material control strategies, genotoxic impurities, cleaning validation, and colorimetry. Dr. Pack has published on the topics of HILIC applications, Raman spectroscopy, mass spectrometry, dissolution, and cleaning verification.