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) …
Scientific and regulatory activities initiated by the US Food and Drug Administration to foster approvals of generic dry powder inhalers: quality perspective
N El-Gendy, CM Bertha, M Abd El-Shafy… - Advanced Drug Delivery …, 2022 - Elsevier
Regulatory science for generic dry powder inhalation products worldwide has evolved over
the last decade. The revised draft guidance Metered Dose Inhaler (MDI) and Dry Powder …
the last decade. The revised draft guidance Metered Dose Inhaler (MDI) and Dry Powder …
[HTML][HTML] Advancements in the design and development of dry powder inhalers and potential implications for generic development
Dry powder inhalers (DPIs) are drug–device combination products where the complexity of
the formulation, its interaction with the device, and input from users play important roles in …
the formulation, its interaction with the device, and input from users play important roles in …
Bioequivalence evaluations of generic dry powder inhaler drug products: similarities and differences between Japan, USA, and the European Union
R Kuribayashi, T Yamaguchi, H Sako, T Takishita… - Clinical …, 2017 - Springer
In Japan, the development of generic oral dry powder inhaler (DPI) drug products for
marketing approval has recently increased. The Pharmaceuticals and Medical Devices …
marketing approval has recently increased. The Pharmaceuticals and Medical Devices …
In Vitro Considerations to Support Bioequivalence of Locally Acting Drugs in Dry Powder Inhalers for Lung Diseases
SL Lee, WP Adams, BV Li, DP Conner, BA Chowdhury… - The AAPS journal, 2009 - Springer
Dry powder inhalers (DPIs) are used to deliver locally acting drugs (eg, bronchodilators and
corticosteroids) for treatment of lung diseases such as asthma and chronic obstructive …
corticosteroids) for treatment of lung diseases such as asthma and chronic obstructive …
[HTML][HTML] Inhalation dosage forms: a focus on dry powder inhalers and their advancements
S Magramane, K Vlahović, P Gordon, N Kállai-Szabó… - Pharmaceuticals, 2023 - mdpi.com
In this review, an extensive analysis of dry powder inhalers (DPIs) is offered, focusing on
their characteristics, formulation, stability, and manufacturing. The advantages of pulmonary …
their characteristics, formulation, stability, and manufacturing. The advantages of pulmonary …
[HTML][HTML] Dry powder inhalers in the digitalization era: current status and future perspectives
S Xiroudaki, A Schoubben, S Giovagnoli, DM Rekkas - Pharmaceutics, 2021 - mdpi.com
During the last decades, the term “drug delivery systems”(DDSs) has almost fully replaced
previously used terms, such as “dosage forms”, in an attempt to emphasize the importance …
previously used terms, such as “dosage forms”, in an attempt to emphasize the importance …
Pharmacokinetic, pharmacodynamic, efficacy, and safety data from two randomized, double-blind studies in patients with asthma and an in vitro study comparing two …
PT Daley-Yates, DA Parkins, MJ Thomas, B Gillett… - Clinical …, 2009 - Elsevier
Background: The use of dry-powder inhalers (DPIs) to administer respiratory medicines is
increasing, and new DPIs are likely to be developed because of expiring patents. However …
increasing, and new DPIs are likely to be developed because of expiring patents. However …
Improvements in and relating to carrier particles for use in dry powder inhalers
JN Staniforth - 1995 - Google Patents
First worldwide family litigation filed litigation Critical https://patents. darts-ip. com/? family=
10768844&utm_source= google_patent&utm_medium= platform_link&utm_campaign …
10768844&utm_source= google_patent&utm_medium= platform_link&utm_campaign …
Recent developments in dry powder inhalation (DPI) formulations for lung-targeted drug delivery
Background Dry powder inhalation (DPI) formulations have been widely studied for the
treatment of respiratory diseases, including COVID-19, which have become common and …
treatment of respiratory diseases, including COVID-19, which have become common and …
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