We have discussed bridging studies in this blog before in the context of the phase 1 bridging study to link the safety and efficacy of the RLD to the proposed drig product. So, what is meant by a bridging study for CMC* purposes?During the 505(b)(2) drug development process we often change the formulation, components or API. [...]
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You are currently browsing the Drug Kennel weblog archives for the day Monday, March 16th, 2009.
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