Qualification to regulators is what validation means to scientists Definition Biomarker qualification is about thinking through the full chain of evidence to prove that a biomarker can be used for a particular clinical decision. HDL serum cholesterol, for instance, is great for evaluating risk of heart disease but not for...
Biomarker qualification is about thinking through the full chain of evidence to prove that a biomarker can be used for a particular clinical decision.
HDL serum cholesterol, for instance, is great for evaluating risk of heart disease but not for evaluating effectiveness of treatments to improve cardiovascular health. There is no such thing as a “good biomarker” in a vacuum. Decisions to use biomarkers are always dependent on the intended applications.1 Sadly, this is not something that most biomedical researchers think about when they do biomarker discovery.
Biomarker guided therapeutic decisions require developing and validating biomarkers. Specifying what these criteria are requires constant meta-scientific innovation. It... (read 586 more words →)
Clozapine has been a highly underutilized drug for decades https://psychiatryonline.org/doi/full/10.1176/appi.ps.201700162
40+ years ago when people were investigating the mechanism of action of clozapine, they knew that some of its benefits might have had to do with muscarinic receptors as well. In fact, some of these investigations were done at Pfizer! https://paperpile.com/shared/shUc~GTZ0T3qFvQ84LykSmA
So the story that cobenfy has a brand new mechanism of action isn't quite right, but it is the first approved drug to have deliberately targeted muscarinic receptors.
Request for Information on synthetic data evaluations
RFP
Causal effect predictiveness of a surrogate asks whether the effects of an intervention on S, the surrogate, is predictive of the effects of the intervention on the gold standard outcome. I’m still looking for a causal effect predictiveness angle on making decisions on synthetic data.
So far, I've found two interesting commentaries, one in the Lancet and the other from the FDA on evaluating "synthetic datasets".
- Lancet article
... (read more)