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With Bioequivalence, 1+1 Won't Always Make 2

Emil W. Ciurczak, Principal, DoraMaxx Consulting
Wednesday, February 27, 2013 00:01 EST

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Emil W. Ciurczak
Emil W. Ciurczak  
3/26/2013 8:59:27 AM
User Rank Blogger
Actually, yes, there was (is)
The patent for several strengths of OxyContin (Purdue Pharma) was based on two of X = 2X approach. Hence the trouble in 2001-4...Since coming back with abuse resistant formulations, they are now "good buys" and are making profits again.

But, from my personal point of view: there are enough real problems with ANY drug...could we at least test what we sell?

3/25/2013 5:28:07 PM
User Rank Blogger
Are there other examples of bioequivalence dilemmas published? If so, are they just as significant as the example with budeprion?

3/3/2013 10:28:56 AM
User Rank Survivor (White Belt)
Re: Hard to believe!
Yes it is hard to believe that regulators would allow "extrapolation." But how else, other than human testing, does one quantify drug release from a 300 mg dose? Dosing is a huge issue in late-stage testing and approval. If this issue is real it makes no sense to take short-cuts later on when approving larger doses. On the other hand perhaps the single 300-mg dose would have behaved "biosimilarly" to the 2x150 mg doses.


Emil W. Ciurczak
Emil W. Ciurczak  
2/27/2013 12:46:49 PM
User Rank Blogger
Re: Hard to believe!
The idea of bioequivalence is actually somewhat new. When the FDA was established, generics weren't as prevalent as they are today. Just as with cyber-hacking and the like, laws evolve for bioequivalece, too.

What was OK years ago (e.g., 10-20 tablets per lot for release) is constantly being updated to reflect what we have learned. [Remember mercury salts were used as medicine once, too.]


I am also sure that there will be a number of tests (lab or otherwise) that will help with the multilevel conundrum, but it takes 1) time, 2) money, ahd, most importantly, 3) the will to do the right thing.

Charles Butcher
Charles Butcher  
2/27/2013 12:14:04 PM
User Rank Survivor (White Belt)
Hard to believe!

I see that the FDA wrote: "...the bioequivalence studies were performed using the 150 mg strength, and the results were extrapolated to establish bioequivalence of the 300 mg product. This methodology was based on FDA's guidance at the time the products were approved."
It seems odd that the FDA should over-simplify to that extent. Surely it's obvious that there could be an important difference between the two dose forms?

That said, are further clinical trials essential? Surely a lab analysis could get us 90 percent of the way there?

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