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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: Biomaven who wrote (1807)10/7/2000 3:31:38 PM
From: smh  Read Replies (1) | Respond to of 52153
 
Peter,

<...a skeptic could even quarrel with the whole "individualized toxicology" notion. Let's say we can in fact identify the individuals that are at risk from a particular drug. Would the FDA approve a non-breakthrough drug on this basis? I have my doubts that they would in the current environment.>

What about the "individualized efficacy" notion? I gather the approval process does not yet allow for pharmacogenomic screening of test subjects. I have no specific example to cite (actually out on a clueless limb here) but presumably there are cases of drugs which may fail (or may have failed) statistical tests of efficacy in the undifferentiated population, but which would be successful under the same criteria in an appropriately targeted subset. It would seem that these issues must be addressed sooner rather than later.

Just trying to achieve a rudimentary understanding of what is going on in this area. Comments are welcome.

SMH



To: Biomaven who wrote (1807)10/9/2000 9:13:34 AM
From: nigel bates  Respond to of 52153
 
Of course if it's a one-time test, the results get stored in the patient's record and then a computer program advises on the drug/dosage, maybe it would work. Not going to happen quickly, though.
Depends what you mean by quickly (bearing in mind how long, for example, clinical trials can take...). Sensible use of technology ought to be able to eliminate the hassle factor. Check out (eg) -
ga.org
It's not been updated for some time, but apparently they are starting a 100 baby trial later this year.

nig