[HTML][HTML] The global bioequivalence harmonisation initiative (GBHI): Report of EUFEPS/AAPS fourth conference
HH Blume, M Mehta, G Beuerle, A Dorantes… - European Journal of …, 2021 - Elsevier
This report provides a summary of the 4 th International Conference on Global
Bioequivalence Harmonisation Initiative (GBHI) that was co-organised by the European …
Bioequivalence Harmonisation Initiative (GBHI) that was co-organised by the European …
[HTML][HTML] Novel approach for real-time monitoring of carrier-based DPIs delivery process via pulmonary route based on modular modified Sympatec HELOS
X Zhang, Y Cui, R Liang, G Wang, X Yue, Z Zhao… - … Pharmaceutica Sinica B, 2020 - Elsevier
An explicit illustration of pulmonary delivery processes (PDPs) was a prerequisite for the
formulation design and optimization of carrier-based DPIs. However, the current evaluation …
formulation design and optimization of carrier-based DPIs. However, the current evaluation …
Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development
Y Gong, FX Barretto, Y Tsong, Y Mousa, K Ren… - The AAPS Journal, 2024 - Springer
Abstract On October 27–28, 2022, the US Food and Drug Administration (FDA) and the
Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled …
Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled …
[HTML][HTML] A real-time and modular approach for quick detection and mechanism exploration of DPIs with different carrier particle sizes
Y Cui, Y Huang, X Zhang, X Lu, J Xue, G Wang… - … Pharmaceutica Sinica B, 2022 - Elsevier
Dry powder inhalers (DPIs) had been widely used in lung diseases on account of direct
pulmonary delivery, good drug stability and satisfactory patient compliance. However, an …
pulmonary delivery, good drug stability and satisfactory patient compliance. However, an …
Inhalation Devices and Formulations
JG Clarke, AP Savage - 2022 - books.rsc.org
A historical analysis of scientific publications relating to oral drug delivery and inhaled drug
delivery (Figure 7.1), whilst highlighting a later emergence of publications relating to inhaled …
delivery (Figure 7.1), whilst highlighting a later emergence of publications relating to inhaled …
Evaluation of the Sensitivity and Robustness of Modified Chi-Square Ratio Statistic for Cascade Impactor Equivalence Testing Through Monte Carlo Simulations
A Kurumaddali, D Christopher, H Strickland… - AAPS …, 2020 - Springer
The objective of this work was to study the performance of the modified chi-square ratio
statistic (mCSRS test) proposed for cascade impactor (CI) profile equivalence testing. The …
statistic (mCSRS test) proposed for cascade impactor (CI) profile equivalence testing. The …
Pharmacometric Evaluation of In Vitro and In Vivo Methods for Bioequivalence Assessment of Orally Inhaled Drug Products
A Kurumaddali - 2019 - search.proquest.com
Background: Unlike oral drugs, the bioequivalence (BE) assessment of orally inhaled drug
products (OIDPs) is challenging, as drug plasma concentrations are downstream to the sites …
products (OIDPs) is challenging, as drug plasma concentrations are downstream to the sites …