The pre-IND phase of drug development is the foundation upon which all development-related activities (including registration) depend. It is, therefore, essential to give proper forethought and attention to this initial, all-important step of the drug-development...
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,...
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 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. These small, freshwater, tropical fish share genetic and biochemical...
Drug development is a complicated, often convoluted process. The ability to predict drug toxicity in humans from nonclinical data remains a major challenge. Since you can’t “erase” an adverse event, optimization of preclinical dose selection is...
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. Joint negotiation of package deals with government and health...
