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Best Practice Database Provides Benchmarks for Fixed-Dose Combination (FDC) Drug Development
Date:11/13/2008

CHAPEL HILL, N.C., Nov. 13 /PRNewswire/ -- Bio-Pharma executives are increasingly finding value in the research products and services offered by Best Practices, LLC and in particular in use of the on-demand benchmark repository known as the Best Practice Database. ( http://www.BestPracticeDatabase.com ) Although documents from the database may be accessed and downloaded individually, many commercial and operations leaders have come to find outstanding value in membership to the database which not only provides full access to all content as needed, but also includes services such as new research alerts, invitations to participate in topical new studies and ongoing advisory services to address research needs.

As biopharmaceutical companies focus on line extensions and new product development opportunities, fixed-dose combination (FDC) products have become an increasingly important segment of the market. In an effort to better understand the development strategies and issues for new FDC products, a recent study was conducted by Best Practices, LLC, with insights available in the newly published report, "Product Commercialization Excellence: Preparation and Management of Fixed-dose Combination (FDC) Drug Products." The research explored a number of critical questions, including: whether organizations seek additive or synergistic FDC drugs; why companies chose either a bioequivalence or clinical evaluation approach; and whether organizations are using external consultants and for what purposes.

Among the many benchmarks included in this study are timeframes for both bioequivalence and clinical evaluation development approaches and the number, types and frequency of tests required. Executives who are responsible for fixed-dose combination (FDC) drug development can use this data to assess the effectiveness and efficiency of their FDC drug product development programs.

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