Mark Copley of Copley Scientific answers questions about upcoming changes to nebulizer testing requirements. Q: What are the new nebulizer testing requirements, and when do they come into force? A: Both the United States Pharmacopoeia (USP) and the European Pharmacopoeia (Ph. Eur.) are introducing new monographs relating to the testing of nebulizers within the … [Read more...] about A Q&A with Mark Copley about new nebulizer testing requirements
Features
UK issues new outcomes strategy for COPD and asthma
Acknowledging that in its treatment of asthma and COPD, "we deliver health outcomes that fall some way behind those achieved by the best-performing countries, or the outcomes public health specialists and clinicians tell us are achievable," the UK's National Health Service (NHS) has issued a new strategy for treatment of those diseases. The document says that it aims … [Read more...] about UK issues new outcomes strategy for COPD and asthma
AANMA sponsors inhaler design contest
The Allergy & Asthma Network Mothers of Asthmatics (AANMA) is currently sponsoring an "Ultimate Inhaler Contest," challenging lay people to "invent the ultimate inhaled medication device." The organization is a 25-year-old US-based non-profit that provides education to and advocates for asthma patients. The contest is open to all ages, with submissions grouped into … [Read more...] about AANMA sponsors inhaler design contest
Imaging/CFD methods could save millions in OINDP development costs
Jan De Backer, CEO of Antwerp-based FluidDA, calculates that the combination of biomedical imaging and computational fluid dynamics offered by his company has the potential to reduce development costs for OINDPs by hundreds of millions of dollars. According to De Backer, FluidDA’s functional imaging methods provide significantly more sensitive parameters for measuring … [Read more...] about Imaging/CFD methods could save millions in OINDP development costs
Next RDD Europe will be in Athens, Greece
At the end of the 2011 RDD Europe conference in Berlin, co-organizers RDD Online and Aptar Pharma announced that the next RDD Europe meeting will take place in Athens, Greece at the Athens Hilton Hotel, May 21-24, 2013. Aptar Pharma’s Pierre Carlotti explains that the organizers are making an effort to choose varied locations for the RDD Europe conference, and … [Read more...] about Next RDD Europe will be in Athens, Greece
RDD Europe — Day 3
On the final day of RDD Europe 2011 in Berlin, most of the focus turned to the abbreviated impactor method (AIM) and efficient data analysis (EDA), but the first session of the morning was devoted to advanced imaging methods for understanding drug delivery. The first speaker, Henk Versteeg of Loughborough University, described his method for studying transport of … [Read more...] about RDD Europe — Day 3
RDD Europe–Day 2
The most intense discussions of Day 2 of RDD Europe occurred during an afternoon session on LABA and LABA/ICS postmarket trial design in which industry representatives differed with each other and with regulators over the usefulness of LABA safety trials such as those now demanded by the FDA. The afternoon culminated with a panel discussion that featured fairly blunt … [Read more...] about RDD Europe–Day 2
RDD Europe — Day 1
At the kickoff of RDD Europe 2011 in Berlin, Peter Byron of co-organizer RDD provided some attendance figures to the assembled delegates, telling the crowd that they number 470 in all, with ~85% of attendees representing pharmaceutical companies and ~9% coming from academia. A number of regulators are also in attendance. According to Byron, delegates have come … [Read more...] about RDD Europe — Day 1
Gateway Analytical holds grand opening
Gateway Analytical, a subsidiary of ChemImage Corporation, held a grand opening celebration at its new facility in Gibsonia, Pennsylvania on April 12, 2011. The 3,000-sq ft cGMP facility actually opened for business in October, 2010, offering services for the forensics, materials, and pharmaceutical industries. The festivities were meant to take place on February 1, … [Read more...] about Gateway Analytical holds grand opening
FDA approval times for OINDPs have decreased
A review of FDA approval times for OINDPs presented at the recent IPAC-RS conference verifies that the process has sped up considerably over the last decade. According to the poster authored by Ray Ormiston of IPAC-RS’s Global Regulatory Affairs and Outreach Committee, whereas most of the 20 OINDP submissions from 1992-2003 took 2-3 years for approval, and several … [Read more...] about FDA approval times for OINDPs have decreased