The increased requirement for combined chronic toxicity and fertility assessment of biologics has led to greater use of sexually mature non-human primates. Older animals have different needs compared to the younger, adolescent animals with which we are used to...
Both pharmaceutical industry and regulatory professionals acknowledge the importance of balancing timely access to new medicines with the need for thorough review of drug safety and efficacy data. A new study, funded by the Pew Charitable Trusts (to be published in...
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. There are about 50 such guidances planned. Below are a few select highlights relevant to the...
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. “Most agree that the industry is not merely going through a prolonged...
A previous entry detailed Dried Blood Spot Analysis: Preclinical Pros and Cons. Additional preclinical considerations include the ambiguity of acceptance by global regulatory agencies, none of which have issued definitive rulings on how they’ll handle New Drug...
