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DRUG DEVELOPMENT SCIENCES

DANIEL A. SPYKER, Ph.D., M.D., Adjunct Professor, Biopharmaceutical Sciences

Dr. Daniel Spyker has a Ph.D. from the University of Minnesota in Electrical Engineering and an M.D. from the University of Virginia where he was a member of the Internal Medicine faculty in the Division of Clinical Pharmacology for 10 years. He was a founder and CEO of a software company specializing in pharmacokinetic applications. In 1988 Dr. Spyker joined a Charlottesville contract research organization, as Director of Clinical Services before joining the FDA. He served as a Medical Officer in the CDER's Pilot Drug Evaluation Staff from 1990 to 1993 when he joined CDRH as acting Deputy Director in the Division of Cardiovascular, Respiratory and Neurological Devices. In 1999 he joined Purdue Pharma as Sr Medical Director and 2003 moved to Genentech in South San Francisco as Director in Pharmacokinetic and Pharmacodynamic Sciences. He is board certified in Internal Medicine, a diplomate of the American Board of Medical Toxicology, a diplomate of the American Board of Clinical Pharmacology and Adjunct Professor in the Division of Clinical Pharmacology at the Uniformed Services University of the Health Sciences in Bethesda. Dr. Spyker has been an active and enthusiastic participant in the design and reporting of clinical trials and in drug and medical device labeling since 1990.

SELECTED PUBLICATIONS:

  1. Rumack BH, Spyker DA: An acetaminophen dosing error in a child -- Commentary. Int J Med Toxicol 6(2):8, 2003.
  2. Cone EJ, Fant RV, Rohay JM, Caplan YH, Ballina M, Reder RF, Spyker DA, Haddox JD: Oxycodone involvement in drug abuse deaths: a DAWN-based classification scheme applied to an oxycodone postmortem database containing over 1000 cases. J Anal Toxicol 27(2): 57-67, 2003.
  3. Dart RC, Goldfrank L, Chyka P, Lotzer D, Woolf AD, McNally J, Olson KR, Scharman E, Snodgrass WR, Geller RJ, Spyker DA, Kraft M, Lipsy R: The Combined Use of Evidence-Based Literature Analysis and Consensus Methodology to Develop Guidelines for Stocking of Emergency Antidotes in the United States. Annals Emergency Medicine 36:126-132, 2000.
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