Inner Ear Pharmacokinetic Studies and Consulting are now available though
The field of drug delivery to the inner ear is still very young and has many, many complications.
In animal studies, if the fluids are not sampled properly there can be serious measurement artifacts that distort drug measurements and render the study useless. We know how to do pharmacokinetic studies properly. We have pioneered the method of "sequential sampling", in which very small fluid samples are collected one after the other. These measurements can be used to quantify the drug gradients from base to apex along the ear.
Most locally-applied drugs do not disperse evenly throughout the ear and gradients of distribution are common. As a result, interpretation of perilymph or tissue drug measurements typically requires computer modeling. We have available "FluidSim", the most comprehensive inner fluids simulation program in the field.
Nothing is worse for the inner ear drug delivery field than to have people collecting data at great expense that are distorted or uninterpretable (see our page on the "Serial Barriers" problem). This can lead to bad decisions based on flawed data or incorrect interpretation. There are numerous instances where this has already happened. It is even worse when someone has a well-designed drug therapy in-hand which proves to be ineffective in humans because it wasn't delivered properly. Drug therapies that work in the mouse do not necessarily work in the human. Computer simulations clearly demonstrate the specific difficulties that have to be overcome. Serious pitfalls can be avoided if the studies are properly planned.
We provide guidance and advice to people at all stages of the drug-delivery-to-the-inner-ear pipeline.
This covers a wide range of issues from the design of PK studies in animals, getting FDA approval for clinical studies, and to the final protocol specification used to deliver drugs to the ear in the clinic. We will help ensure that the drug therapy you are planning is fully optimized for success. It is important to talk with us in the early stages of your planning. We cannot fix badly-designed studies.