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
Features
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
Civitas looks to turn Parkinson’s patients “ON” with inhaled L-dopa
Some day in the not-too-distant future, a dry powder inhaler once used to deliver insulin may help Parkinson’s patients overcome some of the most debilitating symptoms of the disease. Back in 2008, in the wake of the Exhubera failure, Eli Lilly backed out of its partnership with Alkermes on the AIR inhaled insulin project. As a result, Alkermes shuttered a $40 … [Read more...] about Civitas looks to turn Parkinson’s patients “ON” with inhaled L-dopa
A Q&A with the FDA’s Bill Doub
Bill Doub is Lead Chemist, R&D in the FDA's Division of Pharmaceutical Analysis, which is part of the Office of Pharmaceutical Science in the Center for Drug Evaluation and Research (CDER) Q. What does the Division of Pharmaceutical Analysis do? A. Over 30 years or so that I have worked for the FDA, the role of the lab has changed. Historically, we did almost … [Read more...] about A Q&A with the FDA’s Bill Doub
How an abandoned inhaler project led to a CDMO makeover
A new, or at least new-ish, contract development and manufacturing company called Formex LLC launched on March 8, 2013 after its parent company, Biotech Investment Group (B.I.G.), acquired all of the assets formerly belonging to Akela Pharma subsidiary PharmForm. Formex's services are the same as PharmaForm's, including formulation development and GMP clinical … [Read more...] about How an abandoned inhaler project led to a CDMO makeover
DDL 24 — Day 3
DDL24 concluded on Friday, December 13 with a half day of presentations and the final exhibition session. Bo Olsson of AstraZeneca kicked off the morning with a talk titled, "Validation of a General In Vitro Approach for Prediction of Total Lung Deposition in Healthy Adults." After Olsson's presentation, last year's Pat Burnell award winner, Martin Rowland of the … [Read more...] about DDL 24 — Day 3