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To: ifinnegan
The drug is exactly the same.

Actually, the drug substance is the same. However, differences can be introduced in the way the drug is prepared from the drug substance. As a simple example: If the drug substance is a component of a mold growth (common to many antibiotics) then the actual drug must be extracted, cleaned, dried, etc. to become a dispensable drug. Not all of these processes are identical to the original patent process (as mentioned in the article) and the 'reverse-engineering' may cause something to diverge in the active ingredient.

Excipients differ.

True, and can often be considered by the consumer. It may be significant. It may not. Your mileage may vary.

However, there is another potentially major issue. When my brother was in the army, some of his men (and their families) were having infections that were not clearing up after prescribed antibiotics. No one knew why until one of the sick kids when the hospital and they saw complete tablets in his stool discharge. The generic antibiotic (non-US manufacturer) had compressed the tablets so hard that they were not dissolving during their passage through the patient's digestive system. That's not a chemistry issue, it's a mechanical issue. It wouldn't show up on the list of ingredients. It might not show up during 'qualification' since the manufacturing process can be changed after certification as a 'generic.' But it made the generic medication ineffective.

I'm okay with generic drugs and generally use them. Sometimes we find that the 'excipients' cause stomach distress that the brand names drugs don't cause, and we take that into account. But it's not automatically 'just as good.' You (me, 'one') just need to be careful, aware of the risks, and recognize your own responsibility to make a decision. Don't just assume that Big Brother will take care of you.
44 posted on 09/16/2019 1:35:29 PM PDT by Phlyer
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To: Phlyer

“Actually, the drug substance is the same”

Not sure where “actually” comes from because this is what I said.

Interesting example of small molecule drug being isolated from a mold, for example.

I’d guess that is rare now. I’d wonder if it falls under BLA now?


48 posted on 09/16/2019 1:44:50 PM PDT by ifinnegan (Democrats kill babies and harvest their organs to sell)
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