IrTxRx said:
Sal, salt, NaCL is all the same. With regards to manufacturing/purity, all generic manufacturers must meet the same stringent production and testing requirements that brand name manufacturers do.
I work as a lab manager for a pharmacuetical company. I disagree that generics undergo the same amount of testing as the original patent protected compound.
We have to do a prescribed amount of toxicological testing in various species before we can even consider testing a product in humans. These include two year tox studies to see if there are any adverse effects. We run maximum tolerated dose studies, pharmacology studies, dose range finding studies and efficacy studies. These are the in vivo (in live subjects) studies. Concurrent with this we run the in vitro studies on cells, cell lines or fractions. We are looking at possible carcinogens (Ames mutation studies), formation of active metabolites, effects on the heart, liver and lung cell lines. Again all prior to testing in man.
The first studies in man are called Phase 1 and are performed on young healthy males. There is no attempt do check efficacy typically. You just want to look at adverse effects and see how well tolerated the compound is.
Phase 2 trials involve the target population and you are looking at both efficacy and adverse effects. Phase 3 are larger studies involving the target population. Often Phases 2 and 3 are double blinded placebo studies. Some patients get the active drug and some get placebo (sugar pills). Neither the patients nor the Drs and nurses at the study site know what the patients receive.
All of this data is reviewed along the way and reviewed by the FDA they make suggestions and we may have to repeat a certain study at different doses or we may do another study they want.
I work in a pharmacokinetics lab. We receive plasma samples drawn from the subjects over a time course period. Our job is to quantify the drug levels in the body. You do not want a drug that has a short half life and you need to take a pill every hour. Nor do you want a drug that hangs around forever and builds up in the body raising concerns about toxic levels.
The dosage form is determined prior to testing in man. That involves a whole barrage of physoi-chemical tests. They test for purity, characterize and quantify any impuritie for both the drug and any excipients added to the pills. They run dissolution studies and stability studies.
With a lot of luck we get a drug to market. After the patent expires generics can enter the market. They need only run bioequvalence studies. BE studies are simple. Give half the patients the real drug. Give the other half the generic compound. Take plasma samples and send them of to the PK lab. If the generic has the same plasma levels it is assumed to be bio-equilavent and thus the same so it can be marketed.
The synthetic pathway, the excipients, they can be completely different than the original.
BE studies are usually sufficient. But the generic compound has a mere fraction of the testing of the original. This can be enough to keep physicians from prescribing the generic. You tag line is an old Dupont slogan - better living through chemistry. Dupont Pharmaceuticals no longer exists. They were the manfacturer of Coumadin a very popular blood thinner. Coumadin is also known as warfarin - the key ingredient in rat poison. Coumadin has a Narrow Therapuetic Index meaning a little can help save your life but a little more can kill you. DuPont sucessfully protected their Coumadin franchise for over 30 years because doctors did not believe the BE testing was enough for a NTI drug.
Generics have there place I agree, but thet do not undergo the same degree of testing as the original.
If you read this far I thank you for your time.
Phil
