Bioequivalence and Pharmacokinetic Studies
KFI manages all in-life aspects of these studies and then submits samples for analysis to a subcontracted bioanalytical laboratory. We have several preferred labs that manage the study requirements from method development and validation to sample analysis and reporting. However, we are equally willing to work with a bioanalytical laboratory of your choice.
KFI highly recommends conducting pilot pharmacokinetic studies in order to determine preliminary bioequivalence of test article, refine the timing and number of sampling time points, ensure a properly powered statistical study, identify if the test article is a highly variable drug, and allow time for bioanalytical method refinement. Together, these help to ensure that the GLP BE study is scientifically sound and will move through regulatory review with little to no substantive comments.
With almost 20 years of regulatory research experience, KFI has built a solid reputation for leading sponsors through early PK/PD studies into well-planned, properly designed pivotal BE studies that readily pass FDA and EMA regulatory approval. Contact us for more information and discover what KFI can do for your research program.