Drug Safety: IOM Pharmacovigilance Report

An Institute of Medicine (IOM) committee report, recommends that the FDA take proactive steps to continue monitoring drug safety after initial approval and throughout the market lifecycle.   Post-market evidence is far greater than what the FDA has when deciding upon...

Preclinical Offshoring Anticipated to Continue: Survey

In the next 2-5 years, large pharmaceutical companies plan to increase outsourcing of preclinical work, with emphasis on Discovery and non-GLP Toxicology. 888 casino arab   This trend is driven by the reductions in internal preclinical capability within Big Pharma....

High-throughput ADME Screening Technologies

High throughput (HT) Absorption, Distribution, Metabolism, and Excretion (ADME) screening technology is the current push from Big Pharma to be outsourced through contract research organizations (CROs).  Shifting also is the ADME regulatory emphasis; the FDA has...

Nonclinical Toxicology: FDA Guidance Agenda for 2012

The Federal Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has issued a list of planned draft and final guidance documents for release in 2012. لعبة الكازينو   There are about 50 such guidances planned.  Below are a few select highlights...

Nonclinical Toxicology Sector Predictions for 2012

Growth in demand for nonclinical toxicology services will be weak for the foreseeable future analysts said after the Society of Toxicology (SOT) annual meeting in San Francisco this past week. كيف تربح في الروليت   “Most agree that the industry is not merely going...