Toxicological Insights for the Global Pharmaceutical Industry
Health Canada is increasing inspection frequency and offers a new online tool for tracking regulatory actions against drug manufacturing companies.
Light-field laser generates 3D movie of entire brain to create a “living” brain map.
Increased “fast-tracking” of drug approvals necessitates a counterbalance of enhanced postmarket surveillance and ethical governance throughout the lifecycle of a drug.
CDER guidances of particular interest to nonclinical pharmaceutical toxicologists are slated to issue in 2012.
This article offers a concise review of the topic of off-label drug use including its definition, prevalence, and implications for drug safety.
CDER will use natural language processing to mine published literature to address issues relevant to drug safety.
A recent survey identified trends in safety biomarkers and their utilization in drug development.
New procedure cage attaches directly to an animal’s home cage and eliminates hand capture or use of other restraints, creating calmer handling environment.
This slide presentation gives excellent perspective of past and future trends for the global pharmaceutical market, with emphasis on FDA approvals of NME.
A resource table listing FDA-approved drugs with pharmacogenomic information / biomarkers in their labels.