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....

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...

FDA Pre-IND Meetings: Why, When and How

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...

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,...