Pharmacokinetics, the study of the time course of drug concentrations in tissue compartments and it relevance to the time course of drug action, is a critical component of the Drug Development package. Understanding fundamental aspects of the Pharmacokinetic/Pharmacodynamic relationship begins early and the regulatory expectations come with their own unique guidances.
Beginning with the earlier bioavailability work upto the modelling of complex data from multidose toxicokinetics our consultants can assist you in the interpretationof data and predictive exercises needed for the clinical program and the preparation of this section of regulatory submissions.
For earlier studies, rapid screening and quick turn around together with low cost can be critical to the selection of the lead. We keep up with the non-GLP labs that can do this work for you and provide rapid access to a number of choices.
In gearing up for the GLP program, knowledge of drug absorption, tmax and Cmax and AUC are key details necessary for dose selection and can guide you in optimizing formulations before committing to this large expense. You need also to be considering method transfer and validation as part of that GLP effort. There is much to be considered. We have the experience to guide you and iron out rough spots along the way.
Do you need data on metabolism? Are you confident that your test species are appropriate when it comes to human metabolism? Do you have differences in protein binding across species and how important is that - should you know that before you select your lead candidate? What in vitro work will be acceptable as surrogate? What in vivo work metabolism work do you need? And what about that radiolabelled standard for whole body autoradiography or mass balance work? When should you do these costly studies? How much risk is there if you leave it for now? We can help with answers to all of these questions...