Complexity in Early Phase Clinical Trials with Dr. Oren Cohen
Clinical Trial Podcast | Conversations with Clinical Research Experts
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Endpoints in Phase One PK and Safety
Primary end points are going to be the the pharmacokinetics and safety. Secondary endpoints, maybe exploratory, you may have some biomarker exploratory endpoints. But generally speaking, you know, you have very limited power. I mean, these are, these are small cohorts. And that's pretty much it. So, not a whole lot of controversy around endpointsYou're looking for PK, and you're looking for safety. You can also throw in some,. some exploratory biomarkers.
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