Generics, chemisimilars and biosimilars: is clinical testing fit for purpose?

JB Warren - British Journal of clinical pharmacology, 2013 - Wiley Online Library
The effectiveness and safety of generic drugs are backed by sound physicochemical control
and regulatory bioequivalence acceptance criteria. Statistical testing of bioequivalence …

Modeling of pulmonary deposition of agents of open and fixed dose triple combination therapies through two different low-resistance inhalers in COPD: a pilot study

T Erdelyi, Z Lazar, Á Farkas, P Furi, A Nagy… - Frontiers in …, 2023 - frontiersin.org
Introduction Inhalation therapy is a cornerstone of treating patients with chronic obstructive
pulmonary disease (COPD). Inhaler devices might influence the effectiveness of inhalation …

Development of budesonide nanocluster dry powder aerosols: formulation and stability

N El-Gendy, S Huang, P Selvam, P Soni… - Journal of …, 2012 - Elsevier
The physical and chemical stability of dry powder aerosol formulations is an essential
component in the development of an inhaled therapeutic. The pharmaceutical processing …

The interaction between the oropharyngeal geometry and aerosols via pressurised metered dose inhalers

T Ehtezazi, I Saleem, I Shrubb, DR Allanson… - Pharmaceutical …, 2010 - Springer
Purpose This study investigated the effect of oropharyngeal geometry on inhaled aerosol
characteristics via pressurised metered dose inhalers (pMDIs), both with or without spacers …

Tamas Erdelyi1*, Zsofia Lazar1, Árpád Farkas2, Peter Furi2, Attila Nagy3 and Veronika Müller1

JB Fink, M Abdelrahim, B Antus… - … Research Questions for …, 2024 - books.google.com
Methods: We recruited control subjects (Controls, n= 17) and patients with stable COPD (S-
COPD, n= 13) and those during an acute exacerbation (AECOPD, n= 12). Standard …

Predicting Inhaled Drug Dose Generated by Mesh Nebulizers

YC Hsu, HH Li, LC Chiu, WC Chiang… - Journal of Aerosol …, 2023 - liebertpub.com
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 …

[PDF][PDF] Application of the EU guidelines for pharmacokinetic studies of locally acting orally inhaled drug products

S Dissanayake - Respiratory Drug Delivery, 2010 - researchgate.net
In view of the limited sensitivity of traditional therapeutic effect models to compare generic
and reference orally inhaled products (OIPs), the revised European regulatory guidance on …

Дозированные аэрозольные ингаляторы, активируемые вдохом

НА Вознесенский - Практическая пульмонология, 2005 - cyberleninka.ru
54 увеличению эффективности более чем в 2 раза при уменьшении риска осложнений
со стороны верхних дыха тельных путей [10, 11]. Легочная депозиция препарата может …

Drug Delivery Using Aerosols: Challenges and Advances in Neonatal Pediatric Subgroup

S Saikia, A Das, Y Pathak - Handbook of Lung Targeted Drug …, 2021 - api.taylorfrancis.com
Frequent administration of aerosolized drugs to pediatric patients is often for facilitating
mucus clearance, preventing and treating infections, enhancing pulmonary blood flow, etc …

[PDF][PDF] A REVIEW ON DRY POWDER INHALERS

PK Desu, M Bellamkonda - ijapbjournal.com
A Dry powder inhaler (DPI) is a dry-powder product that provides medicine to the lungs.
Asthma, bronchitis nd COPD are common in treating breathing disorders. DPI interests have …