FDA Changes Expected with PDUFA V

The average cost of developing a drug was $1.3 billion as of January 2011.  The average first-cycle approval rate for standard new molecular entities (NME) has increased from an average of 30% in 1992 to 38% this year.  Priority NMEs have fared better with the FDA,...

Nonclinical Cardiotoxicity Testing: Stem Cell Use

Prospective identification and potential amelioration of cardiotoxicity is a critical component of contemporary drug development, particularly for targeted therapies (e.g., tyrosine kinases) in oncology that are designed to inhibit critical signaling pathways shared...

Zebrafish: Preclinical Screening and Toxicity Assessment

Zebrafish offer a nonclinical model for the high-throughput screening of drug compounds, including toxicity assessment, with resolution at the cellular level in living vertebrate organisms. لعبة بينغو   These small, freshwater, tropical fish share genetic and...

Adverse Preclinical Events – Now What?

Drug development is a complicated, often convoluted process.  The ability to predict drug toxicity in humans from nonclinical data remains a major challenge. قوانين البوكر   Since you can’t “erase” an adverse event, optimization of preclinical dose...

Is Pharmaceutical Collaboration an Oxymoron?

With the rise of combination therapy – the use drugs with different mechanisms of action to combat a specific disease state – comes the need to address medical costs and reimbursement issues. مواقع رهان   Joint negotiation of package deals with government and...