4 ms·

I think the natural engineer intuition is that if a drug is just a chemical, and generic and name-brand drugs are the same chemical, how could there possibly be

I think the natural engineer intuition is that if a drug is just a chemical, and generic and name-brand drugs are the same chemical, how could there possibly be any difference? Don't be duped by advertising, save the money, be rational, etc. One interesting case where there was a real problem was with generic extended-release bupropion (an antidepressant). The time-release mechanism on one of the generics didn't work correctly, although the manufacturer managed to get it past the FDA (they actually tested only a 150mg dose, and extrapolated the results to approve the 300mg dose). https://blogs.sciencemag.org/pipeline/archives/2012/10/18/the_generic_wellbutrin_problem_whose_fault_is_it https://blogs.sciencemag.org/pipeline/archives/2012/10/18/th...

dRaBoQ 7y ago
This was one of the cases discussed in the book. The book said the manufacturer didn't test the 300mg because it might cause seizure.
Scoundreller 7y ago
It gets complicated fast. Sometimes small differences in formulations will be mostly irrelevant (oh no, your ibuprofen takes a few extra minutes to absorb, but will 99% absorb under almost all circumstances). But other times, a new crystalline form exists that you weren’t aware of and destroys your entire ongoing production. Same molecule, but different structure that’s too stable and doesn’t dissolve effectively. See: ritonavir.