Approximately 450 OINDP experts gathered May 5-8 in Antibes, France for the 10th anniversary iteration of RDD Europe, which featured scientific presentations and posters, a series of workshops, a technical exhibition, and numerous networking opportunities. Organized by RDD Online and Aptar Pharma, RDD Europe began in Paris in 2005, with about 300 OINDP specialists … [Read more...] about Looking back at RDD Europe 2015
Features
Complementary particle characterization techniques for faster DPI development
By Paul Kippax, Product Group Manager, Malvern Instruments Optimizing a dry powder inhaler (DPI) to achieve the desired emitted dose and aerodynamic particle size distribution (APSD) can be made significantly faster and easier by using data acquired by laser diffraction and morphologically directed Raman spectroscopy (MDRS) as a supplement to cascade impaction … [Read more...] about Complementary particle characterization techniques for faster DPI development
Upcoming workshop asks whether a biopharmaceutical classification system for inhaled drugs is possible
Since 2000, developers of immediate-release oral drugs have been able to request waivers of in vivo bioequivalence studies based on the FDA's Biopharmaceutics Classification System (BCS). Now a workshop sponsored by the AAPS Inhalation and Nasal Technology Focus Group, the USP, and the FDA will explore whether the same type of classification system can be developed … [Read more...] about Upcoming workshop asks whether a biopharmaceutical classification system for inhaled drugs is possible
DDL 25 in review
DDL 25 conference chair Gary Pitcairn opened the Silver Anniversary edition of Drug Delivery to the Lungs by welcoming approximately 550 attendees to the Edinburgh International Conference Centre. With the meeting's rapid growth in attendance over the past few years, it has now eclipsed RDD as the largest meeting of OINDP specialists held annually. At the end of … [Read more...] about DDL 25 in review
DDL celebrates its 25th anniversary with a look to the future
Twenty-five years after its first meeting in a Glaxo Group Research lecture theater, the Aerosol Society's annual Drug Delivery to the Lungs conference marks its silver anniversary with DDL 25, taking place December 10-12 at the Edinburgh International Conference Centre. Unlike the past few years, when symposia conducted by associated groups occupied the Wednesday … [Read more...] about DDL celebrates its 25th anniversary with a look to the future
Q&A with Mark Copley on test methods and equipment for generic inhaled drug development
Recent product-specific pharmacopeial monographs intended to assist developers of inhaled generic drugs call for the use of test equipment not specified in the USP/Ph. Eur. chapters on orally inhaled products. In this Q&A, Copley Scientific Sales Director Mark Copley answers questions about the equipment and methods recommended for testing of fluticasone … [Read more...] about Q&A with Mark Copley on test methods and equipment for generic inhaled drug development
Bing Li of the FDA answers frequently asked questions about nasal spray ANDAs
At the recent Orlando Inhalation Conference, Bing Li of the FDA’s Division of Bioequivalence in the Office of Generic Drugs (OGD) of the Center for Drug Evaluation and Research (CDER) provided a list of frequently asked questions about Abbreviated New Drug Applications (ANDAs) for nasal sprays along with her answers. This is the second of two articles based on … [Read more...] about Bing Li of the FDA answers frequently asked questions about nasal spray ANDAs
Practical advice on nasal spray ANDA submissions from Bing Li of the FDA
At the recent Orlando Inhalation Conference, Bing Li of the FDA's Division of Bioequivalence in the Office of Generic Drugs of the Center for Drug Evaluation and Research (CDER) offered practical advice for companies submitting Abbreviated New Drug Applications (ANDAs) for generic nasal sprays. Between 1987 and December 2013, Li says, her office received 85 nasal … [Read more...] about Practical advice on nasal spray ANDA submissions from Bing Li of the FDA
Team Consulting now under team ownership
Many of the attendees at the upcoming RDD meeting in Puerto Rico who stop by Team Consulting's table to check out the company's Occoris inhaler probably won't realize that the Team staff with whom they are chatting are some of the company's new owners. Founded in 1986, Team has developed a wide range of medical devices, including more than 20 inhalers. Until March … [Read more...] about Team Consulting now under team ownership
Presentations from the Orlando Inhalation Conference now available
The organizers of the recent Orlando Inhalation Conference have made all of the presentations from the meeting available to the public. Approximately 200 OINDP specialists gathered March 18-20, 2014 at the University of Florida Research and Academic Center in Orlando, Florida for a conference co-hosted by the International Pharmaceutical Aerosol Consortium on … [Read more...] about Presentations from the Orlando Inhalation Conference now available