Publications about IPAC-RS

IPAC-RS efforts are making a significant and positive impact on the scientific and regulatory environment for orally inhaled and nasal drug products. These efforts have been recognized by relevant media outlets. In particular, The Gold Sheet - a trade magazine covering pharmaceutical and biotechnology quality control topics - followed closely the FDA/IPAC-RS discussion of the science behind the regulatory requirements for orally inhaled and nasal drug products. For example:

IPAC-RS's Delivered Dose Uniformity Proposal was mentioned in the May 2002 and July 2003 issues.
The January 2002 issue of the Gold Sheet highlighted the work of the Leachables and Extractables Team, and provided extensive coverage of hot topics in leachbles/extractables for a variety of dosage forms.

The ITFG/IPAC-RS Collaboration’s BA/BE Team met with the Agency on 26 April 2001 to discuss in-vivo testing for nasal solutions. A report on this meeting and the FDA's views on this issue are covered in the June 2001 issue of The Gold Sheet. The issue also highlights the Team's three proposed approaches to risk management.

The June 2001 issue of The Gold Sheet reported on the ITFG/IPAC-RS Tests and Methods Team's technical paper, Recommendations for Tests and Methods, submitted to the Agency in May. The article highlights the Team's proposals regarding several tests for MDIs described in the draft CMC OINDP Guidances.

The seminal AAPS/FDA/USP Workshop "Regulatory Issues Related to Drug Products for Oral Inhalation and Nasal Delivery", held on 3-4 June 1999, received a thorough review in the August 1999 issue of The Gold Sheet. The IPAC Statement at the Workshop was reprinted in full in this issue.

The history of IPAC-RS and ITFG/IPAC-RS Collaboration was reviewed in the American Pharmaceutical Review (Spring 2002 issue) - "the leading quarterly review of business and technology for the pharmaceutical industry throughout North America."

Another general overview of the Consortium’s work is presented in Addressing Regulatory Issues through Pharmaceutical Consortia S. Lyapustina, L. Nagao and M. D. Capizzi Clinical Research and Regulatory Affairs.  23 (1): 21-34 (2006).