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Drug Makers Urged To Collect Own Excipient Metals Data To Comply With ICH Q3D

While leveraging published data may help pharmaceutical manufacturers understand the general risks of using excipients with known elemental impurities, it is less helpful in understanding specific risks.

Manufacturing Quality

Best of the Blog: IN VIVO, May/June 2009

Our favorite blog posts related to stories not covered elsewhere in this month's IN VIVO.
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Big Pharma May Be Big Player in Follow-On Biologics Market

This article is a reprint from the April 2008 issue of The RPM Report. As Congress works on an approval pathway for follow-on biologics, generic drug companies are jockeying for investors' attention. But given that most generic manufacturers may be ill-equipped to handle the development of follow-on proteins, some analysts think the real opportunity is where you'd least expect: inside Big Pharma and biotech.

Big Pharma May Be Big Player in Follow-On Biologics Market

As Congress works on an approval pathway for follow-on biologics, generic drug companies are jockeying for investors' attention. But given that most generic manufacturers may be ill-equipped to handle the development of follow-on proteins, some analysts think the real opportunity is where you'd least expect: inside Big Pharma and biotech.
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