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January 25, 2006
If It's Not One Thing. . .
I'm starting to wonder how we're going to get many drugs even as far as the clinic these days. I don't think I'm alone in feeling that it's just one thing after another.
Modern mass spectrometry techniques can find all sorts of interesting metabolites for your compounds after they've been dosed in animals. If you look hard enough, you're likely to find some structures that you don't want (epoxides, quinone precursors, and other potentially toxic beasts). In the old days, we'd never have seen them, but now we get a chance to worry about them.
There's always our good friend the Ames test to make you hold your breath. It's true that not every Ames positive compound is going to be a mutagen in humans, but it's also true that no one is going to develop one because they happen to feel lucky, either.
Anyone who doesn't hold their breath when their drug candidate goes into two-week rat testing hasn't been in the business long enough. Even if the rodents act normally during the whole thing, you can't breath normally again until the tissues are examined by the histopathologists, Perfectly reasonable-looking rats can be hiding amazing things at the microscopic level.
And for the last few years we've had to worry about QT prolongation. That's a cardiac side effect that can lead to very serious trouble - sometimes. And we have some ways to check for it early in development, which work - sometimes. The list of drugs that came to the market before we realized all this is rather impressive.
All this is why I wonder when I read about small startup companies with three or four compounds in clinical trials. Have they really jumped through all the hoops that a big company has the resources for? And if not, how much worse off are they for it?
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