Modeling of Lung Dose and Prediction of Exposure
Emmace has significant commercial experience in developing and characterizing inhaled medicinal products and medical devices and is therefore a suitable company to engage for any customer planning for the development of an inhaled medication, either as a new product or a generic product.
Lung Dose and Prediction of Exposure
As a pivotal part of these services we provide building a Preludium model that is based on available physicochemical and pharmacokinetic data for each active pharmaceutical ingredient. We also support the Client in identifying key product or batch specific attributes and associated experimental assays and test programs available via the analytical services provided by Emmace.
Read more about IVIVC/Prediction Lung Dose.
For advising services in this area, Emmace collaborates with Per Backman Consulting (PBC) in a seamless manner. Read more about Per Bäckman here.
In support of product design, setting of clinically relevant specifications and batch selection for bioequivalent (BE) studies we offer:
- Mathematical modeling of lung dose and regional deposition along the airways is based on cascade impactor data and inhalation flow profiles for medicinal aerosol products (nebulizers, pMDIs and DPIs).
- Sensitivity analysis to explore impact of Client specified variations in
- product performance (delivered dose, lung dose, cascade impactor data and dissolution rate);
- patient handling (inhalation flow profiles); physiology (age, disease and airway remodeling) on predictions of lung deposition pattern and local/systemic PK ( AUCt, Cmax) following oral inhalation
- Predictions of absolute and relative (e.g. Test/Reference) systemic exposure (AUCt, Cmax) in support of batch selection and design of clinical bioequivalence studies.
- Evaluation of clinical pharmacokinetic studies to establish
- understanding of study outcomes and
- in vitro – in vivo correlations when Client specified variations in key product attributes are an integral part of the study design
