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.
Inhalation Technology and 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
Read more about IVIVC/Prediction Lung Dose.
Advanced Advisory Services
By Senior Adviser Per Bäckman, PhD
Mechanistic Modeling and Predictive Testing
- Development of mechanistic models to simulate aerosol deposition and drug absorption in the respiratory tract.
- Expertise in linking aerosol quality, dose distribution, and dissolution propeties to clinical outcomes, ensuring robust in vitro–in vivo correlations.
- Use of advanced computational tools like Mimetikos Preludium™, designed for accurate pulmonary drug delivery predictions.
Strategic Product Development
- Guidance on inhalation product formulation, including optimization of dry powders, MDIs, and nebulizers.
- Comprehensive evaluation of critical product attributes, from particle size to dose consistency, tailored for regulatory and clinical success.
Regulatory Science Leadership
- Leadership in establishing an Inhaled Biopharmaceutical Classification System (iBCS) to streamline regulatory submissions for inhaled therapeutics.
- Expertise in navigating FDA and global regulatory landscapes, backed by contributions to FDA-funded research initiatives.
Collaborative Innovation
- Proven track record of multi-institutional collaborations, including partnerships with academic leaders and international organizations.
- Advisory services extend to leveraging partnerships for joint research, grant applications, and publication strategies.
Dr. Per Bäckman, a leading expert in pharmaceutical inhalation science with nearly three decades of experience, offers unparalleled advisory services to optimize drug development and regulatory processes. His expertise integrates cutting-edge scientific insights with practical solutions tailored to industry needs.
Dr. Bäckman’s unique combination of academic rigor, practical expertise, and regulatory knowledge ensures transformative results for pharmaceutical development teams. Whether optimizing product design, enhancing regulatory submissions, or integrating predictive modeling into development pipelines, Dr. Bäckman provides actionable solutions that align with both scientific and commercial goals.
Contact Dr. Per Bäckman to elevate your inhalation product development to new heights!
