Bioequivalence of inhaled medications [comment]
نویسندگان
چکیده
منابع مشابه
Bioequivalence of inhaled drugs.
Correspondence: E. Derom, Dept of Respiratory Diseases, University Hospital, De Pintelaan 185, B-9000 Gent, Belgium. It is generally accepted that inhalation therapy is the most effective way to treat patients with asthma or chronic obstructive pulmonary disease (COPD). Indeed, inhalation of relatively small doses of drug not only results in high, local concentrations in the airways the site of...
متن کاملConsiderations in establishing bioequivalence of inhaled compounds.
INTRODUCTION Generic inhalers are often perceived as inferior to their branded counterparts; however, they are safe and effective if they can meet the regulatory requirements. The approach to assess bioequivalence (BE) in oral dosage form products is not sufficient to address the complexities of inhalational products (e.g., patient-device interface); hence, more considerations are needed and ca...
متن کاملScientific Rationale for Determining the Bioequivalence of Inhaled Drugs.
In recent years, pathways for the development and approval of bioequivalent inhaled products have been established for regulated markets, including the European Union (EU), and a number of orally inhaled products (OIPs) have been approved in the EU solely on the basis of in vitro and pharmacokinetic data. This review describes how these development pathways are structured and their implications...
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Abbreviations: AE: Adverse Event; AUC(0-t’): Area Under the Curve from Zero (Pre-Dose) to the Time of Last Common Measurable Time Point Within Subject; BLQ: Below the Limit of Quantitation; CI: Confidence Interval; Cmax: Maximum Plasma Concentration; COPD: Chronic Obstructive Pulmonary Disease; CV: Coefficient of Variation; DPI: Dry Powder Inhaler; FF: Fluticasone Furoate; FP: Fluticasone Propi...
متن کاملPro-arrhythmic and pro-ischaemic effects of inhaled anticholinergic medications
The majority of deaths in COPD are from cardiovascular causes. Several large randomized controlled trials demonstrate that inhaled anticholinergic agents ipratropium and tiotropium increase the risk of serious cardiovascular events, including cardiovascular mortality. Tiotropium Respimat is associated with a statistically significant increased risk of mortality (RR 1.52; 95% CI 1.06 to 2.16) an...
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ژورنال
عنوان ژورنال: British Journal of Clinical Pharmacology
سال: 1992
ISSN: 0306-5251
DOI: 10.1111/j.1365-2125.1992.tb05635.x