Pharmacokinetic Bioequivalence between Generic and Originator Orally Inhaled Drug Products: Validity of Administration of Doses above the Approved Single Maximum Dose.
Sign Up to like & getrecommendations! Published in 2024 at "Molecular pharmaceutics"
DOI: 10.1021/acs.molpharmaceut.4c00479
Abstract: Pharmacokinetic bioequivalence of orally inhaled drug products is a critical component of the US FDA's "weight of evidence" approach, and it can serve as the sole indicator of safety and effectiveness of follow-on inhalation products… read more here.
Keywords: bioequivalence; inhaled drug; single maximum; drug products ... See more keywords
Predicting Inhaled Drug Dose Generated by Mesh Nebulizers.
Sign Up to like & getrecommendations! Published in 2023 at "Journal of aerosol medicine and pulmonary drug delivery"
DOI: 10.1089/jamp.2022.0055
Abstract: Background: The lung dose of nebulized drugs for spontaneous breathing is influenced by breathing patterns and nebulizer performance. This study aimed to develop a system for measuring breath patterns and a formula for estimating inhaled… read more here.
Keywords: inhaled drug; dose; drug dose; formula ... See more keywords
Comparing Lung Geometrical Areas of interest in Gamma Scintigraphy as Assessment Tool for Inhaled Drug Deposition
Sign Up to like & getrecommendations! Published in 2018 at "European Respiratory Journal"
DOI: 10.1183/13993003.congress-2018.pa1022
Abstract: Background: Planar gamma scintigraphy is a powerful tool in therapeutic aerosol studies to evaluate inhaled drug delivery to the lungs. Alas, different laboratories use different approaches for analysing and quantifying aerosol lung deposition and its… read more here.
Keywords: deposition; interest; inhaled drug; gamma scintigraphy ... See more keywords