The objective of a recent survey by Cambridge Health Associates was to identify trends in safety biomarkers and their utilization in drug development. Regardless of company size, recurrent themes for assessing drug safety in early preclinical development were noted....
An innovative Procedure Cage invented by Dr. Ryoichi Nagata, SNBL USA chairman, is at the center of a comprehensive program designed to significantly raise standards for non-human primate (NHP) care and thereby improve the quality of preclinical data collected. The...
Analysis and overview of new drug reviews from 1993 through present by an over 20-year-active FDA veteran of drug approvals, Dr. John Jenkins (Director, Office of New Drugs, Center for Drug Evaluation and Research). The presentation includes review times and...
Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labels may contain information on genomic biomarkers and can describe: Drug exposure and clinical response...
What is new about PDUFA V? Congress, the media, and the public have a history of boiling down the issue to whether drugs are safe or not safe. In reality the issue is benefit versus risk. In addition, this judgement needs to be aligned with that of the patients...
Many drug hypersensitivity reactions are HLA-linked, meaning that they will occur much more often or even exclusively in individuals who have certain variants of the HLA gene. A new study elucidates the specific mechanism leading to HLA gene-linked hypersensitivity...
