When opportunity met aspirational goals: accelerator MS, microdosing and absolute bioavailability studies

“…the pharmaceutical industry became quite adept at deriving an estimate of absolute bioavailability without necessarily developing an intravenous formulation and performing the additional nonclinical and clinical studies.” As the pharmaceutical industry has continued to struggle under the burden of the current competitive and economic climate, we have all been increasingly challenged to find faster, better, and/or less expensive ways to discover and develop the next wave of innovative medicines. This has been especially challenging in the realm of clinical pharmacokinetic (PK)-study conduct, where studies in ‘lower-cost’ regions are complicated by each country’s unique clinical study regulatory approval process (creating a...