How can machine learning and multiscale modeling benefit ocular drug development?
The eyes possess sophisticated physiological structures, diverse disease targets, limited
drug delivery space, distinctive barriers, and complicated biomechanical processes …
drug delivery space, distinctive barriers, and complicated biomechanical processes …
Scientific and regulatory activities initiated by the US food and drug administration to foster approvals of generic dry powder inhalers: bioequivalence perspective
Regulatory science for generic dry powder inhalers (DPIs) in the United States (US) has
evolved over the last decade. In 2013, the US Food and Drug Administration (FDA) …
evolved over the last decade. In 2013, the US Food and Drug Administration (FDA) …
A multiplex inhalation platform to model in situ like aerosol delivery in a breathing lung-on-chip
A Sengupta, A Dorn, M Jamshidi, M Schwob… - Frontiers in …, 2023 - frontiersin.org
Prolonged exposure to environmental respirable toxicants can lead to the development and
worsening of severe respiratory diseases such as asthma, chronic obstructive pulmonary …
worsening of severe respiratory diseases such as asthma, chronic obstructive pulmonary …
Prediction of the carrier shape effect on particle transport, interaction and deposition in two dry powder inhalers and a mouth-to-G13 human respiratory system: A CFD …
Documentation of comparability between generic inhaler designs and the reference listed
drug (RLD) inhalers is essential for regulatory approval of the products. Such assessments …
drug (RLD) inhalers is essential for regulatory approval of the products. Such assessments …
[HTML][HTML] A critical analysis of the CFD-DEM simulation of pharmaceutical aerosols deposition in extra-thoracic airways
Recent advances in the characterization of the human respiratory system and in multi-phase
flow dynamics in complex geometries have led numerical simulations to play an expanding …
flow dynamics in complex geometries have led numerical simulations to play an expanding …
Mechanistic modeling of generic orally inhaled drug products: A workshop summary report
RL Walenga, C Butler, BA Craven… - CPT …, 2023 - Wiley Online Library
In silico mechanistic modeling approaches have been designed by various stakeholders
with the goal of supporting development and approval of generic orally inhaled drug …
with the goal of supporting development and approval of generic orally inhaled drug …
Validating CFD predictions of nasal spray deposition: Inclusion of cloud motion effects for two spray pump designs
Momentum transfer from nasal spray droplets to the surrounding gas may create droplet
cloud motion and influence nasal deposition patterns. The objective of this study was to …
cloud motion and influence nasal deposition patterns. The objective of this study was to …
[HTML][HTML] A critical analysis of the CFD-DEM simulation of pharmaceutical aerosols deposition in upper intra-thoracic airways: Considerations on air flow
A well-corroborated numerical methodology ensuring reproducibility in the modeling of
pharmaceutical aerosols deposition in the respiratory system via CFD-DEM simulations …
pharmaceutical aerosols deposition in the respiratory system via CFD-DEM simulations …
Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: a workshop overview
A Babiskin, F Wu, Y Mousa, ML Tan… - CPT …, 2023 - Wiley Online Library
Abstract 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 …
(FDA) and the Center for Research on Complex Generics cosponsored a live virtual …
Establishing quantitative relationships between changes in nasal spray in vitro metrics and drug delivery to the posterior nasal region
Nasal sprays are typically characterized using in vitro spray metrics such as spray cone
angle and droplet size distribution. It is currently not clear how these in vitro metrics correlate …
angle and droplet size distribution. It is currently not clear how these in vitro metrics correlate …