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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.

Modeling of Lung Dose and Prediction of Systemic Exposure at Emmace with Per Bäckman, Peter Elfman and Lena Heinz Wannerberg
Modeling of Lung Dose and Prediction of Systemic Exposure at Emmace with Per Bäckman, Peter Elfman and Lena Heinz Wannerberg

Lung Dose and Prediction of Exposure

As an integral part of these services we will provide the customer with purpose-built model(s) based on available physicochemical and pharmacokinetic data for each active pharmaceutical ingredient. We will also support the customer in identifying key product or batch specific attributes and associated experimental assays and test programs available via the analytical services provided by Emmace.

For more information, please contact advise@emmace.se.

Read more about IVIVC/Prediction Lung Dose.

In support of product design, setting of clinically relevant specifications and batch selection for BE studies we offer:

  • Mathematical modeling of lung dose and regional deposition along the airways base 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 
    • (i)  product performance (delivered dose, lung dose, cascade impactor data and dissolution rate);
    • (ii) 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 
    • (i) understanding of study outcomes and
    • (ii) in vitroin vivo correlations when Client specified variations in key product attributes are an integral part of the study design

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