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Saturday, January 19, 2008


BioPharma Podcast Series: Regulating Biotech Therapeutics- Part 1

Listen to BioPharm International's Editor-in-Chief Laura Bush interview Stephen Kozlowski on the challenges of regulating biotech therapeutics.

This is part one of a two part podcast. In this podcast, Dr. Kozlowski discusses the challenge of implementing risk-based approaches, how Quality by Design applies to biotech drugs; protein characterization, the structure-function relationship, and immunogenicity.

Interview: Stephen Kozlowski, MD, the director of the Office of Biotechnology Products (OBP) in the Office of Pharmaceutical Science, in the FDA's Center for Drug Evaluation and Research.

Click here to listen to the podcast.
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