Recent advances in realistic in vitro testing have made it possible consider the patient in the development of orally inhaled and nasal drug products (OINDPs) at ever earlier stages. We are able to see how our products aerosolise under flow conditions akin to those produced by a patient or measure the drug deposited in a physical model of a human throat or nose but these advances capture only a small fraction of the variability in airway morphology, device use and physiological processes that exist between patients and between diseases.
Truly physiologically based simulations can take these data alongside real information about patients: the surface areas of their airways, the rates of mucociliary clearance in their airways, and the way they use their device to simulate the exposure of the delivered drug both locally and systemically. This approach can not only be used to predict the outcome of clinical studies but also run hundreds or thousands of theoretical scenarios to address questions such as “how will the local targeting of my nasal product influence systemic exposure?”, “what is the maximum dose of my poorly soluble drug that can be delivered before the cilia clear most of it from the airways?” or “how will changing from one device to another influence the delivery of my drug?”.
This webinar will present a series of clear examples of the questions physiologically-based pharmacokinetic (PBPK) modelling can address in OINDP development. It will not only be a basic introduction to how these models work but, more importantly, a discussion of how these models interface with in vitro and pre-clinical data. Taking this knowledge into your own drug product development will allow you to design studies that will benefit from in silico methods, addressing questions that neither in vitro nor in silico approaches could alone.
The future of complex drug product development will use a combinations of in vitro and in silico approaches. To make this partnership work there must be mutual understanding on both sides. If you are a drug product developer who would like to expand the scope of questions your testing can address or are just curious about how PBPK models can be used for OINDPs then this is the webinar for you.
Key Learning Objectives
- Identify the drug development questions PBPK modelling can address
- Design an in vitro study that could be input into a PBPK model
- Analyse PBPK simulation results to guide drug development decision making
- Apply this thinking to your own drug development problems
