Developing generic orally inhaled drug products has been very challenging due to the previous need to perform comparative clinical endpoint (CCEP) studies, which are difficult to pass due to high interpatient variability on device use and lung physiology. FDA has recently updated Product Specific Guidances to replace these studies with additional in vitro testing, supported by in silico studies. These additional methods are new and more complex, designed to be more “realistic” to clinical settings, but this brings method development challenges that could delay your submission. Furthermore, the “optional” modelling studies have led to ambiguity over when and how to deploy these in silico tools.
The webinar will provide an overview of the changes to the FDA guidance and talk through some case studies of how the new in vitro methods have helped customers to derisk their PK studies due to better correlation vis-à-vis QC methods. Having developed these new analytical methodologies alongside FDA, Nanopharm has rare insight into the challenges faced during method development that can only be gained through experience, and how to factor these into the method development early on. We will highlight some patented analytical technology to reduce uncontrolled variability in test methods and provide greater chances of success.
Secondly, the webinar will provide case studies of how using in silico modelling technologies can further expedite in vitro method development through understanding the most critical variables, followed by the application of similar in silico tools to predict regional deposition and bioavailability in the lungs of patients, considering intra- and inter-patient variability – in both their airway physiology and their use of the drug product - on a clinically-representative scale, to help justify more biorelevant limits for equivalence and support submissions. We will also highlight an ongoing clinical study to validate the accuracy of the models according to regulatory expectations.
Nanopharm’s 10 years of collaboration with FDA, and application of these technologies with our pharma partners, positions us well to support you to accelerate and derisk your ANDA submissions, and can also be applied to reformulation of OIDPs into next generation propellants or alternate dosage forms. Please register for our webinar to learn more.
Key Learning Objectives
- Understand FDA regulations
- Learn some of the nuances of developing the in vitro methods
- Learn how to use in silico modelling to accelerate method development
- Learn how to use in silico modelling to justify widening limits for IVBE studies based on patient factors and variability
