This Month’s Focus: Quality/Compliance
Quality requirements for cascade impactors assigned to batch release testing of a specific drug product; Part III: Implications of Type II error probability
The authors conclude a three-part series describing a new approach to quality requirements for cascade impactors (CIs). Their thesis is that the inhaler testing community, both from the manufacturer and regulator perspectives, should insist that the CI quality specifications be both necessary and sufficient for the testing of batches of drug product for release of that product to the public. Ideally, they hope such methodology would guide developers of new OIPs in making proposals for impactor quality specifications to regulators. In turn, regulators need to assure that specifications are both necessary and sufficient for batch release testing in quality control.
See Part II: The concept of “sufficient” as applied to impactor quality specifications
General Features
Nasal drug delivery: Past, present and future perspectives
Nasal drug delivery has been a mainstay for local indications since the late 1900s. Delivery systems have evolved from less-precise dosing systems to sophisticated devices designs able to protect formulations and achieve reliable dosing. Further advances are anticipated, including connected applications. In addition, intranasal administration has become a trusted route for rescue medications. In the future, unmet needs may also be addressed in niche patient populations.
Back Page: The 2020 AAFA Report: “Asthma Disparities in America: A Roadmap to Reducing Burden on Racial and Ethnic Minorities”
The report demonstrates that “racial gaps in asthma outcomes have not changed over the past 15 years. The burden of asthma in the US continues to fall disproportionately on Black, Hispanic and American Indian/Alaska Native people. The reports also identifies 69 “specific strategies and tactics for prioritizing policies and programs to improve asthma health for Americans most at risk while dismantling systems that fuel harmful disparities.”
Cross-industry organizations: Cross-industry organizations: The DDL Conference: Supporting young scientists and recognizing achievement since 1989
The Drug Delivery to the Lungs Conference, or DDL as it is commonly known, strives to promote the work of young scientists and early career researchers through a variety of awards, grants and programs. These include the Pat Burnell Young Investigator Award, the Emerging Scientist Award and the Career Development Grant, as well as the New Researcher Network, which was launched during DDL2019.
December Content
Initial considerations in the development of “repurposed” drugs for inhalation
Inhalation of repurposed drugs: A promising strategy in PAH treatment
Back Page: Electronic alert can reduce excessive prescribing of short-acting asthma relievers
Cross-industry organizations: ISAM
A preview of RDD® Europe 2021
Previewing the ISAM Congress
Issue Focuses
January: Reference and Buyer’s Resource
February: Product Development/ Contract Testing
April: Instruments
June: Nasal Delivery/Nebulizers
August: Particle Characterization
October: Devices
December: Quality/Compliance
Vicki Schuman
1155 Northland Drive
St. Paul, MN 55120
651-287-5600
Fax 651-287-5650
vschuman@cscpub.com
Inhalation Article Guidelines
Technical article requirements
The article should be technical and educational, but not promotional. It must be new, not previously published and must be at least 50% different from your previous articles or other articles you are simultaneously developing on the same subject.
All discussions of products or technologies must be in an unbiased, non-promotional, educational manner. If your article discusses products that have been commercialized or are in development, please be aware of the following: Inhalation takes a very limited approach in discussing products, usually listing only product name, delivered drug name and company name, unless a description is provided by the particular company that owns a product, such as in a case study article or product news release. In that way, each company can choose the information it wishes to discuss or disclose about its own products, rather than being discussed by an outside party with no ability to comment prior to publication. However, if an article is a case study, presentation of a novel technology or news article written by the owner company or its representative such as a scientist or consultant, we are happy to consider all information or data they wish to disclose, provided it is presented in a fair-balanced manner. Also, please avoid discussing product or development costs and do not make cost comparisons.
The article should be 2,500-3,500 words and must include at least five references or items for recommended reading.
We encourage images and/or data tables and have space for three or four of them. We’re flexible about that number so let us know if you need more image space. We also like to publish an additional photo or illustration at the beginning of the article. Images should be sent as separate files that meet the following specifications: high resolution, 300 dpi at a size of 7 x 7 inches and in only JPG, TIF or EPS formats.
Please be aware, due to copyrights, if you use figures or tables from articles that have been previously published in other journals, you must obtain permission from those journals in order to use the images. If you are an author on the published article in question, you may still need permission but there should be no fees from the other journal. If you are not an author and the other journal wants to charge you fees for usage, please contact us before proceeding. We do not want authors incurring costs in order to publish in Inhalation and there may be alternate approaches to citing information that could be used. Also, “open journals” do not charge for image use. If you have any questions or concerns, please contact us.
Editorial board review and production
All of our articles are peer-reviewed and must be accepted by our editorial board or a designated reviewer in order to be published. When you send us the article, it will go to a member of the board and we will coordinate communication between you. Once an article is accepted, we handle production and you will see the final article in layout before it goes to print or is published in the digital edition.
Contract Testing
Excipients
