This Month’s Focus: Quality/Compliance
Optimizing the role of automation in variability reduction strategies for delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD) testing of inhaled drug products
Semi-automation can enhance the quality of inhaler test data, while at the same time boosting productivity; choosing which tasks to automate and appropriate technology is essential.
Quality requirements for cascade impactors assigned to batch release testing of a specific drug product; Part I: A grassroots look
The thesis presented here is that questions about accuracy and uncertainty of cascade impactor results have not been articulated by the inhaler testing community and that, consequently, producers today hold their cascade impactors to quality criteria that may be neither necessary nor sufficient for a confident batch release decision.
Quality requirements for cascade impactors assigned to batch release testing of a specific drug product; Part II: The concept of “sufficient” as applied to impactor quality specifications
The authors continue describing a philosophy for impactor quality specifications that are sufficient for meeting OIP batch release criteria. 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.
General Features
Back Page: Free San Antonio, Texas program supports children with asthma and their families
SA Kids B.R.E.A.T.H.E. (Building Relationships, Effective ASTHMA Teaching in Home Environments) is a free program that already has 50 children enrolled.
Cross-Industry Organizations: An introduction to the Product Quality Research Institute (PQRI)
The Product Quality Research Institute is a non-profit consortium of organizations that work together to generate and share timely, relevant and impactful information that advances global drug product quality, manufacturing and regulation.
February Content
Accelerating inhalation product development through a combination of outsourcing and bringing key functions in-house
A clinically relevant approach to assess in-vitro bioequivalence for regulatory approval of DPIs – a case study: Comparison of three tiotropium DPIs using a medium OPC throat model and a range of realistic inhalation profiles
Back Page: A report by the European Federation of Allergy and Airways Diseases Patients’ Associations (EFA)
Cross-Industry Organizations: IPAC-RS
Previewing Drug Delivery Partnerships 2020
Previewing the Inhalation & Respiratory Drug Delivery USA Congress
A Preview of Respiratory Drug Delivery 2020 and Joint IPAC-RS Symposium
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
