Methods for measurement of platelet function in the assessment of nonclinical drug safety and implications for translatability

摘要: Abstract Platelets play a pivotal role in normal hemostasis. Drug-induced derangement of platelet function can lead to either an increased bleeding risk when is inhibited or proaggregant state that manifest as thrombosis it exacerbated. In both cases, drug-induced dysfunction serious adverse events patients limit drug prescription ultimately the withdrawal from market. Despite those risks, defects do not appear be highlighted during development; rather they are reported at postapproval stage indicating current preclinical assays and clinical development studies failing capture these liabilities. However, significant progresses have been made testing clinically useful methods now exist for measurement function. This review article discusses describes their advantages disadvantages setting nonclinical safety assess on translatability tests predict patients.