title: Assessing New Technologies in Aerosol Medicine: Strengths and Limitations.
abstract: Aerosols are the mainstay of treatment for pulmonary diseases such as asthma, cystic fibrosis, and COPD. In addition, aerosols are also being used for systemic drug delivery. Patients need devices that are safe, reliable, portable, and easy to use; have few steps in their operation; help them keep track of the remaining doses; are not expensive; and provide age-appropriate positive reinforcement and feedback. Computational fluid dynamics, human factor sciences, and quality by design are now applied to device development. Matching patient, drug, and device remains a challenge. Formulary restrictions, the current status of the industry-academia relationship, and the need to use multiple platforms hinder the process. Patients and families need to participate in the selection of a device that is appropriate for them. Practitioners need comparative data to help them choose the right device. New devices and drugs can be compared with the existing technology using in vitro and in vivo methods (lung imaging, pharmacokinetic and pharmacodynamics studies). Drug manufacturers need to be able to justify coverage of new products by third-party payers by showing a positive cost/benefit relationship. Finally, post-market surveillance is necessary for old drugs with new devices or for new drugs and devices to ensure patient safety.
authors.affiliation: Pulmonology Section, Department of Pediatrics, College of Medicine, University of Arkansas for Medical Sciences, and the Pediatric Aerosol Research Laboratory, Arkansas Children's Hospital Research Institute, Little Rock, Arkansas. berlinskiariel@uams.edu.
authors.forename: Ariel
authors.initials: A
authors.lastname: Berlinski
mesh_terms: D000280:Administration, Inhalation; D000336:Aerosols / Q000008:administration & dosage* / Q000191:economics; D003657:Decision Making; D016503:Drug Delivery Systems / Q000191:economics / Q000379:methods*; D004867:Equipment Design / Q000191:economics; D006801:Humans; D007349:Insurance, Health, Reimbursement / Q000191:economics; D008171:Lung Diseases / Q000188:drug therapy*; D009330:Nebulizers and Vaporizers; D011358:Product Surveillance, Postmarketing / Q000191:economics; D013673:Technology Assessment, Biomedical
chemical_list: D000336:Aerosols
keywords: aerosol; inhaled therapy; technology