Ross Walenga
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View article: Quasi-3D Mechanistic Model for Predicting Eye Drop Distribution in the Human Tear Film
Quasi-3D Mechanistic Model for Predicting Eye Drop Distribution in the Human Tear Film Open
Topical drug administration is a common method of delivering medications to the eye to treat various ocular conditions, including glaucoma, dry eye, and inflammation. Drug efficacy following topical administration, including the drug’s dis…
View article: Impact of Mechanistic Modeling and Simulation Methodologies on Product‐Specific Guidance Development for Non‐Orally Administered Drug Products
Impact of Mechanistic Modeling and Simulation Methodologies on Product‐Specific Guidance Development for Non‐Orally Administered Drug Products Open
The U.S. Food and Drug Administration (FDA) publishes product‐specific guidances (PSGs), with bioequivalence (BE) recommendations for prospective generics. Developing BE recommendations for non‐orally administered drug products including l…
View article: Assessment of drug permeability using a small airway microphysiological system
Assessment of drug permeability using a small airway microphysiological system Open
Background There is a need to reliably predict the permeability of inhaled compounds during the development of new and generic drugs. A small airway microphysiological system (MPS) that can recapitulate the pulmonary air-liquid interface (…
View article: An ingestible device for automated sampling and location tracing in gastrointestinal tract
An ingestible device for automated sampling and location tracing in gastrointestinal tract Open
Fluids sampled from the gastrointestinal (GI) tract are of interest for evaluating the bioequivalence of oral medications, and more generally for evaluating GI-related diseases, and for profiling the individual gut microbiome. Existing opt…
View article: Assessment of ventilation heterogeneity and particle deposition in asthmatics using combined SPECT/CT imaging and computational modeling approaches
Assessment of ventilation heterogeneity and particle deposition in asthmatics using combined SPECT/CT imaging and computational modeling approaches Open
Our cluster-informed CFPD-based approach enhances the understanding of ventilation heterogeneity in asthma and holds potential for refining strategies for inhalational therapies.
View article: Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products
Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products Open
Graphical Abstract
View article: CFD-DEM investigation of the effects of aperture size for a capsule-based dry powder inhaler
CFD-DEM investigation of the effects of aperture size for a capsule-based dry powder inhaler Open
Capsule based dry powder inhalers (DPIs) often require piercing of the capsule before inhalation, and the characteristics of the apertures (punctured holes) affect air flow and the release of powders from the capsule. This work develops a …
View article: The role of capsule aperture size on the dispersion of carrier-based formulation at different air flowrates
The role of capsule aperture size on the dispersion of carrier-based formulation at different air flowrates Open
The effect of capsule aperture size on the aerosol performance of lactose blend formulation was studied using Foradil® (containing 12 μg of formoterol fumarate (FF1) and 24 mg of lactose) dispersed with a powder inhaler Aerolizer® at incre…
View article: Transport and deposition of beclomethasone dipropionate drug aerosols with varying ethanol concentration in severe asthmatic subjects
Transport and deposition of beclomethasone dipropionate drug aerosols with varying ethanol concentration in severe asthmatic subjects Open
This study aims to assess the effects of varying an ethanol co-solvent on the deposition of drug particles in severe asthmatic subjects with distinct airway structures and lung functions using computational fluid dynamics. The subjects wer…
View article: Mechanistic modeling of ophthalmic, nasal, injectable, and implant generic drug products: A workshop summary report
Mechanistic modeling of ophthalmic, nasal, injectable, and implant generic drug products: A workshop summary report Open
For approval, a proposed generic drug product must demonstrate it is bioequivalent (BE) to the reference listed drug product. For locally acting drug products, conventional BE approaches may not be feasible because measurements in local ti…
View article: Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview
Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview Open
On September 30 and October 1, 2021, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics cosponsored a live virtual workshop titled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bi…
View article: Mechanistic modeling of generic orally inhaled drug products: A workshop summary report
Mechanistic modeling of generic orally inhaled drug products: A workshop summary report Open
In silico mechanistic modeling approaches have been designed by various stakeholders with the goal of supporting development and approval of generic orally inhaled drug products in the United States. This review summarizes the presentation…
View article: Predicting systemic and pulmonary tissue barrier concentration of orally inhaled drug products
Predicting systemic and pulmonary tissue barrier concentration of orally inhaled drug products Open
The complex physiology and anatomy of the lungs and the range of processes involved in pulmonary drug transport and disposition make it challenging to predict the fate of orally inhaled drugs. This study aimed to develop an integrated comp…
View article: A quasi-3D model of the whole lung: airway extension to the tracheobronchial limit using the constrained constructive optimization and alveolar modeling, using a sac–trumpet model
A quasi-3D model of the whole lung: airway extension to the tracheobronchial limit using the constrained constructive optimization and alveolar modeling, using a sac–trumpet model Open
Existing computational models used for simulating the flow and species transport in the human airways are zero-dimensional (0D) compartmental, three-dimensional (3D) computational fluid dynamics (CFD), or the recently developed quasi-3D (Q…
View article: Assessment and validation of a hygroscopic growth model with different water activity estimation methods
Assessment and validation of a hygroscopic growth model with different water activity estimation methods Open
Hygroscopic growth models are currently of interest as aids for targeting the deposition of inhaled drug particles in preferred areas of the lung that will maximize their pharmaceutical effect. Mathematical models derived to estimate hygro…
View article: 1D network simulations for evaluating regional flow and pressure distributions in healthy and asthmatic human lungs
1D network simulations for evaluating regional flow and pressure distributions in healthy and asthmatic human lungs Open
This study aimed to introduce a one-dimensional (1D) computational fluid dynamics (CFD) model for airway resistance and lung compliance to examine the relationship between airway resistance, pressure, and regional flow distribution. We emp…
View article: <i>In Silico</i> Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products
<i>In Silico</i> Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products Open
The development of generic, single‐entity, drug–device combination products for orally inhaled drug products is challenging in part because of the complex nature of device design characteristics and the difficulties associated with establi…
View article: Differences in Particle Deposition Between Members of Imaging-Based Asthma Clusters
Differences in Particle Deposition Between Members of Imaging-Based Asthma Clusters Open
Background: Four computed tomography (CT) imaging-based clusters have been identified in a study of the Severe Asthma Research Program (SARP) cohort and have been significantly correlated with clinical and demographic metrics (J Allergy Cl…