Drug safety scientists

Clearly, therefore, those involved in drug safety monitoring need to liase closely with both clinical research and medical information scientists. In addition, those responsible for clinical drug safety must undertake periodic safety update reports (PSURs) at predetermined intervals, in accordance with current International Conference on Harmonisation (ICH) guidelines. Such routine analyses can identify new safety signals as soon as they become detectable. 

Food and Drug Administration scientists evaluate the safety studies to determine whether or not the results support a conclusion that the product can be used safely. Until the mid-1970s, the underlying assumption in the agency review was that the reports submitted to the agency accurately described study conduct and precisely reported the study data. A suspicion that this assumption was mistaken was raised in the agency s review of studies submitted by a major pharmaceutical manufacturer in support of new drug applications for two important therapeutic products. Review scientists observed data inconsistencies and evidence of unacceptable laboratory practices in the study reports. 

SHASHI K. RAMAIAH, DVM, PhD, DACVP, DABT Senior Principal Scientist, Biomarker and Clinical Pathology Lead, Pfizer Drug Safety Research and Development, St Louis, MO 63110, USA... 

Unfortunately, safety-related attrition is still high partly because of less awareness of early signals for toxic effects and partly because more complex and less understood biological processes can culminate in unwanted conditions. This book makes an effort to provide a single tome to help drug discovery scientists... 

Professor Ian K Wong qualified as a pharmacist in 1992. He worked at the former Medicines Control Agency on the Yellow Card system, at the David Lewis Centre for Epilepsy, Northwick Park Hospital and the University of Bradford. In 2002, Professor Wong set up the Centre for Paediatric Pharmacy Research in the School of Pharmacy, University of London, Great Ormond Street Hospital for Children and Institute of Child Health, University of London. His main research interests are paediatric drug safety and health service research. He was awarded a Department of Health Public Health Career Scientist Award in 2002 and Chemists and Druggists Pharmacy Practice Research Medal in 2004 for his research in paediatric medicines. 

An ability to communicate with scientists in both ADME, drug safety, computational chemistry, discovery chemistry, discovery biology, biostatistics, and information technology groups. 

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