The safety of prescription medications in combination with alcohol is an increasing focus for regulatory authorities. In fact, the FDA now has issued guidance on the detailed information it requires for drug submissions. We use this as our starting point to measure the effects of alcohol on the pharmacokinetics and tolerability of medicines, as well as the combined effects of alcohol and medications together on cognitive function and behavior.
Not only can we advise you on your study’s design to find the best way to monitor drug-alcohol effects, we can make recommendations for in vitro studies, formulation development, labeling and regulatory submissions.