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...
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...
Side effect overload on drug labels has less to do with true toxicity and drug safety than with manufacturer liability. Examination of more than 5600 drug labels yielded over half a million side effects. An average drug label and the more commonly prescribed drugs...
Biomarker use in translational medicine is predicated upon preclinical qualification and validation – 2 distinct steps in the biomarker development process. Prior to issue in 2009 (EMA) and 2010 (FDA, PMDA) of the renal-specific DRAFT qualification guidelines,...
Any new drug that penetrates the central nervous system must receive some preclinical analysis of abuse liability potential (Draft Guidance). Usually, it is determined through prior knowledge of chemistry and/or pharmacology of the candidate’s drug class that...
