Validation (pharmaceutical companies)

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Evan

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Message 65115 - Posted: 26 Jan 2010, 12:39:57 UTC

How is validation done by a company using algorithms developed by Rosetta? As I understand it all computer software, equipment, procedures and results have to be replicated to the level demanded by a country's FDA (or similar). This may cost the company vast sums to prove its acceptability.

Therefore if a company uses a successful Rosetta algorithm and finds a suitable drug, what happens if there is an improvement to this algorithm? Do they have to repeat all this expensive validation?
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Message 65116 - Posted: 26 Jan 2010, 14:08:37 UTC - in response to Message 65115.  

How is validation done by a company using algorithms developed by Rosetta? As I understand it all computer software, equipment, procedures and results have to be replicated to the level demanded by a country's FDA (or similar). This may cost the company vast sums to prove its acceptability.

Therefore if a company uses a successful Rosetta algorithm and finds a suitable drug, what happens if there is an improvement to this algorithm? Do they have to repeat all this expensive validation?

Not sure what you mean? If rosetta determines a good bond between a protein and a substrate then the company would have to produce that substrate and test it in the lab, and assuming the rosetta model proved reasonably accurate, then on to FDA trials etc. If a newer rosetta version then calculated a different substrate then that too would have to follow the same process.

Not sure if that answers your question?
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Evan

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Message 65117 - Posted: 26 Jan 2010, 15:20:07 UTC

Not sure if that answers your question?

Yes it does thank you. I was thinking along the lines of once a bond had been produced then an improvement to the model might produce an even better bond, but as you say it would be a different substrate.
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Message 65120 - Posted: 26 Jan 2010, 17:14:06 UTC

You might use an improved algorithm to find another substance that successfully docks with the target. It will virtually by definition dock slightly differently then the first one you found. And therefore potentially be more effective. Since the new compound would not have undergone testing yet, you'd have to start over with proving that it doesn't harm the person being treated and that it is effective at knocking out the target as you claim.
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Message boards : Rosetta@home Science : Validation (pharmaceutical companies)



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