SOURCE: Parenteral Drug Association (PDA)

September 18, 2007 10:31 ET

First Issue of "International Pharmaceutical Quality" (IPQ) Focuses on Applying Quality-by-Design to Biotech

BETHESDA, MD--(Marketwire - September 18, 2007) - Bill Paulson, Editor-in-Chief of "International Pharmaceutical Quality" (IPQ), announced the publication of its premiere issue today. The September/October edition concentrates on how applying quality-by-design (QbD) to biopharmaceuticals is testing the viability of the definitions that have been taking shape in the small-molecule context.

The first issue is being distributed at the upcoming "PDA/FDA Joint Regulatory Conference" and exhibition, September 24-26 in Washington, D.C. IPQ will be mailed bi-monthly to the worldwide pharmaceutical and biopharmaceutical quality regulatory community.

"Establishing the linkage between quality attributes and clinical performance, which is a foundation block for the quality-by-design structure, is a particular challenge in the biotech arena," says Paulson in explaining the issue's focus. "Pathways for tightening this linkage are being explored and discussed. Many ideas are under consideration in the United States, including a QbD biotech submission pilot, expanded comparability protocols for defining the design space and reducing change filing burdens, and a consortium to gather knowledge on the product attribute/clinical performance relationship. Regulators and industry are also meeting in Europe to advance the QbD initiative in the biopharmaceutical area. Implementation of the ICH guidelines Q8-10 for both drugs and biologics is drawing debate, and an industry initiative is underway to help solve the practical problems involved."

"International Pharmaceutical Quality" and related IPQ publications will directly target the relevant issues surrounding international harmonization and help further the discussion about the regulatory approaches appropriate for advancing products and processes. Each issue will provide an in-depth analysis of a key problem area or developing regulatory initiative. IPQ will seek to improve understanding of issues and aid the development of harmonized global regulation of pharmaceutical quality and corporate quality systems.

The new publication is available on a subscription basis for $400 per year for direct subscribers and $160 for government. Paulson will be partnering with the Parenteral Drug Association (PDA) and other associations to offer IPQ to their membership as part of their benefit packages. Limited advertising space will also be available. For information on subscription and advertising, contact Nahid Kiani, at kiani@ipqpubs.com or +1 (301) 656-5900 ext. 128 or visit www.ipqpubs.com.

Contact Information


  • Contact:
    Diana Kaminsky
    Email Contact
    Tel: +1 (301) 656-5900, ext. 145

    Nahid Kiani
    Email Contact
    +1 (301) 656-5900 ext. 128
    www.ipqpubs.com

    International Pharmaceutical Quality
    P.O. Box 30510
    Bethesda, MD 20814
    Tel: +1 (301) 656-5900
    Fax: +1 (301) 986-0296