This article summarizes the historic and current US and European regulations driving human factors. The authors also explore some of the more common cognitive, physical, social and environmental use challenges seen with pMDIs and DPIs and discuss how these devices can challenge patients, the types of research that can be employed to better understand these […]
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This article provides a summary of the current best practices for AIM testing of orally inhaled products, with a focus on dry powder inhalers (DPIs). In addition, this article builds on these best practices with the intention of providing counsel to those considering the implementation of an AIM-based measurement program for DPIs.
With so much recent interest in the use of computational fluid dynamics (CFD) for developing inhalation and nasal products – an entire afternoon at RDD 2008 was devoted to papers on the topic – you may be wondering how to get started using CFD yourself. The benefits are pretty obvious; why spend months tweaking device […]
In genetic association studies of asthma, relevant environmental exposures need to be taken into account, and when assessing the effect of environment, we need to factor in genetic predisposition. If we extrapolate this to identification of the new therapeutic targets for asthma, the data suggest only a proportion of the population will benefit from a […]
A lasting solution would be the adoption of sample-independent quality standards and statistical process controls, for example, by incorporating in the pharmaceutical industry some of the statistical methods standardized by ASTM, ISO and other standard-setting organizations, appropriately adjusted throughout a product’s lifecycle (from early to late development to commercial production).
Fluidda’s “functional respiratory imaging” combines high-resolution, low-dose computerized tomography (CT) scans and computational fluid dynamics (CFD) to yield regional information related to lung structure and function.
To achieve a true step-change in nebulization, next-generation nebulizers need to be designed in such a way that they (1) are inconspicuous during patient use, (2) allow for the patient to conveniently carry the device in everyday life, (3) administer the dose in a shorter time, and (4) preferably do so with only one or […]
Recent developments related to laboratory testing methods are helping to shape an additional form of robust OIP testing that has clinical realism as its prime objective, rather than test method simplicity.
For some time, it has been evident that the USP/Ph.Eur. inlet may not provide the most accurate in vitro realization of aerosol transport through the upper respiratory tract. Recent research undertaken at the University of Alberta on this problem resulted in the development of an “idealized” adult throat geometry from which a new inlet accessory […]
The past few years have seen the leveling off of new molecular entities (NMEs) reaching the market,1-3 partly as a result of increasing drug development costs and higher regulatory standards for drug approval. Yet many opportunities still exist in this changing pharmaceutical market for both innovator and generic pharmaceutical companies who are willing to seek […]