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I work in the field of post-Phase 4 clinical trials which test generic medicines for bioequivalence. We have to adhere to world wide standards of what is known as 'Good Clinical Practice'.
IF the generic was tested against the original first-registered brand, the aim is for as little difference as possible, although there is still variance from person to person (just as there would be with the originator product.) Bioequivalence is considered to be established (meaning a generic may be registered as such) if the rate and extent of release is within 80 - 120% variance from the originator product; these percentages vary from country to country, as well as on the innate variability of each drug (some are just known to be highly variable.)
Further variance comes from a generic being tested against another generic (if the first drug was at 80% absorption, and the second drug is 80% of that one, they can get further and further 'out'; the implications in this case are mainly in dosage amount, so this can be corrected for.) Each generic should ideally be tested against the first such product registered in that country, (which may well be a generic and there's no problem with that), although that doesn't always happen (depends on how jacked the medicines control regulatory body is, in that country). This just means that in one country you may need 150mg and in another, 300mg. You can't always compare against countries, not even within the Brand name, as manufacturing conditions may vary.
Then, as Burgy says, variation can also come from inert ingredients (more especially the different shells or formulations used to make the product release faster or slower, like the SR and XL versions), as well as each individual person's uptake of the drug. Each person's uptake varies, depending on their metabolism and genetic make-up, and there is no such thing as an average person. When we do trials, we have to have enough enough subjects to have meaningful averages and to make a statistical analysis valid.
Also, any drug you take, may alter the blood levels of the other drugs you're taking. Currently the Epilim I'm taking approximately doubles my blood levels of Lamitor (a generic of Lamital). I've also just been switched from the SR to the XL version of WB, so who knows what that will do? You have to trust your pdoc to know what s/he's doing, as s/he has the experience.
Add to the variability mix, unscrupulous and shady companies who fudge results or just make up entire trials which were never conducted. That, fortunately, is easy enough to check - if a company is reputable, they are reputable.
Then add factories that do not adhere to 'Good Manufacturing Practice' (ie temperatures not being kept constant, cheap and faulty packaging etc). Or factories that "unfortunately" burn down just before an inspection (that is a real case!)
I know this is a barrage of information. But there are lots of factors and it's not a simple equation. All of these factors are compelling reasons to follow your doctor's instructions, and preferably to see a psychiatrist, if your needs are complex and the second or third drug you've tried hasn't worked too well. Stick with what YOUR doctor says, regardless of whether it is different from what you hear of another person's treatment.
This post has been edited by moonlightress: Nov 11 2008, 10:31 AM
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