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      03-10-2014, 09:40 PM   #133
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Originally Posted by Z K View Post
Now that I have to say something about.. I worked at a pharmaceutical company. Generic drugs are 100% the same. Generics are drugs that the patent expired and so other manufacturers can now manufacture it. The FDA has all the formulas on file so they are the exact same drugs and everyone has access to the same manufacturing process and formulas.

As for the M3 copy you are talking about, if it doesn't have the same parameters as the original - I wouldn't buy it. You mentioned a replica 99% of people would not be able to tell which means it would be pretty much the same as I expect a 99% replica to have the same performance and build. My argument about the car is simply that Brand does not matter to me. I am not a brand whore. I didn't buy an M3 because I wanted a BMW - I wanted an M3. If that happens to be a Hyundai/KIA M3, then so be it. It'd still be a great car.
Wrong. They are not the same and if you worked in pharma you would know this 100%. Their adverse event profile aren't even the same

I too worked for a pharma company (a little $56B company called Pfizer) before moving into Medical device. The only thing a generic pharmaceutical company needs to guarantee is the active ingredient is the same. Everything else: stabilizers, drug delivery, and mechanism of action, metabolism are not regulated.

Your argument as to why you would buy it is not the point of the argument or the thread. Based on your posts, you would buy a BMW M3 regardless whether it was made by BMW or someone else who has no regard for trademarks or patents that essentially is telling you it's the same

Like I said, we have nothing to argue.
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      03-10-2014, 09:41 PM   #134
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Originally Posted by tony20009 View Post
I get your point and I agree that the process you describe is definitely a fraudulent one. Actually, that's more like theft and fraud. Fake watches aren't quite fabricated the same way. The external design is replicated -- using whatever means they use to do so -- but the guts of the thing, the movements, are just purchased movements of varying qualities. It's more like a BMW body with some other maker's motor inside.

I'm not refuting the ethical/legal point of your comment. I'm just highlighting where there is a difference for the sake of keeping the whole matter in perspective, at least as far as facts are concerned.

All the best.
Man, you are far too articulate for me while I'm on an internet forum!
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      03-10-2014, 09:48 PM   #135
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Originally Posted by RR-NYC View Post
Wrong. They are not the same and if you worked in pharma you would know this 100%. Their adverse event profile aren't even the same

I too worked for a pharma company (a little $56B company called Pfizer) before moving into Medical device. The only thing a generic pharmaceutical company needs to guarantee is the active ingredient is the same. Everything else: stabilizers, drug delivery, and mechanism of action, metabolism are not regulated.

Your argument as to why you would buy it is not the point of the argument or the thread. Based on your posts, you would buy a BMW M3 regardless whether it was made by BMW or someone else who has no regard for trademarks or patents that essentially is telling you it's the same

Like I said, we have nothing to argue.
Unless something has changed that's not correct, bioequivelance has to be established with a generic which includes rates of dissoution and such. Dosage form has to regulate absorbtion in the same way or peak times would be delayed or higher or lower as well. Especially with a sustained release formulation. Inactive ingredients can be whatever they want but that doesn't matter in the scheme of things.
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      03-10-2014, 09:49 PM   #136
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I will never own one, but I won't fly off the handle if someone has a replica. However, I did get a little angry when my brother in law asked how much I paid for my Rolex Explorer II when he paid $150 for a fake Explorer II. However, a few months later, it broke on him. To some extent, you do get what you pay for.

If I were you, I would get an homage watch as opposed to a replica. It will look like the real deal up to about a foot away, then if a watch snob asks, you won't have to deal with a diatribe about how wrong it is to wear a fake. The best quality homages out there are from Alpha. A lot of guys on the watch forums love Alpha. It's a great starter watch too for people who aren't into automatic watches and don't want to blow a grand on something new.

http://www.alpha-watch.com/
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      03-10-2014, 09:52 PM   #137
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Originally Posted by 1MOREMOD View Post
Unless something has changed that's not correct, bioequivelance has to be established with a generic which includes rates of dissoution and such. Dosage form has to regulate absorbtion in the same way or peak times would be delayed or higher or lower as well. Especially with a sustained release formulation. Inactive ingredients can be whatever they want but that doesn't matter in the scheme of things.
I was in the process of changing my post as you responded. I was quick to respond without proofing. I did in fact mean bioequivalance however it's method of metabolism and its stabilizers are not regulated. I've been out of pharma for 12 years even though I was in Israel last year meeting with Teva
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      03-10-2014, 09:56 PM   #138
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Originally Posted by RR-NYC View Post
Wrong. They are not the same and if you worked in pharma you would know this 100%. Their adverse event profile aren't even the same

I too worked for a pharma company (a little $56B company called Pfizer) before moving into Medical device. The only thing a generic pharmaceutical company needs to guarantee is the active ingredient is the same. Everything else: stabilizers, drug delivery, and mechanism of action, metabolism are not regulated.

Your argument as to why you would buy it is not the point of the argument or the thread. Based on your posts, you would buy a BMW M3 regardless whether it was made by BMW or someone else who has no regard for trademarks or patents that essentially is telling you it's the same

Like I said, we have nothing to argue.
Yeah strictly speaking this is correct. Actually I think both of you are correct. Z K is correct in that the chemical composition of the active ingredient is often 100% identical, but there may be (and often are) subtle differences in both the composition and quality of any adjuvants.

Pharmaceutical companies are highly regulated by the FDA and for good reason. Even subtle differences in the manufacturing process can lead to disastrous side effects for the patient, and so a lot of the cost of drugs goes into "over-engineering" (for lack of a better term) the final product. Purification, for example, is not a trivial process. A lot of people probably take it for granted but that's one area (among many) where the process can be "over-engineered" in the pursuit of higher selectivity.
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      03-10-2014, 10:01 PM   #139
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Originally Posted by 1MOREMOD View Post
Unless something has changed that's not correct, bioequivelance has to be established with a generic which includes rates of dissoution and such. Dosage form has to regulate absorbtion in the same way or peak times would be delayed or higher or lower as well. Especially with a sustained release formulation. Inactive ingredients can be whatever they want but that doesn't matter in the scheme of things.
The active ingredients are equivalent, yes, but the bolded portion isn't always correct. It's sometimes correct, and for a lot of the drugs you encounter on a daily basis as a pharmacist the bolded part probably is correct most of the time. One prominent example where it isn't necessarily correct is for vaccine development.
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      03-10-2014, 10:13 PM   #140
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Quote:
Originally Posted by NemesisX View Post
The active ingredients are equivalent, yes, but the bolded portion isn't always correct. It's sometimes correct, and for a lot of the drugs you encounter on a daily basis as a pharmacist the bolded part probably is correct most of the time. One prominent example where it isn't necessarily correct is for vaccine development.
didnt really consider various flu vaccines and such as generics of each other but rather seperate drug entities, but yes injectables usually are more similar in terms of inactive ingredients. i also am going from memory as i havent had need to look at this much since pharmacy school, now im an expert on not getting screwed by insurance companies primarily.
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      03-10-2014, 10:24 PM   #141
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Originally Posted by djpatrick35 View Post
I will never own one, but I won't fly off the handle if someone has a replica. However, I did get a little angry when my brother in law asked how much I paid for my Rolex Explorer II when he paid $150 for a fake Explorer II. However, a few months later, it broke on him. To some extent, you do get what you pay for.

If I were you, I would get an homage watch as opposed to a replica. It will look like the real deal up to about a foot away, then if a watch snob asks, you won't have to deal with a diatribe about how wrong it is to wear a fake. The best quality homages out there are from Alpha. A lot of guys on the watch forums love Alpha. It's a great starter watch too for people who aren't into automatic watches and don't want to blow a grand on something new.

http://www.alpha-watch.com/
+1 Homage is the way to go over counterfeits
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      03-10-2014, 10:36 PM   #142
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if you can't afford the real thing, don't act like you can. stick to the g-shocks.
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      03-10-2014, 11:34 PM   #143
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Originally Posted by TrevorM3 View Post
if you can't afford the real thing, don't act like you can. stick to the g-shocks.
That's why my watch box is full of Fossils, Guess, my favorite is my BMW watch and the Bulova Precisionist http://www.bulova.com/en_us/watch/bu...sionist/96B131
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      03-11-2014, 02:21 AM   #144
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Fakes are for people to pretend. Kind of like a fantasy novel or daydreaming. It does serve this purpose.
Generics and pirated software is different, where the value is in the unpaid use of IP protected design. Ain't nobody going to say it's right to stop generics being used in Africa to save people from aids.. Windows can cost a month's salary for people in developing countries - I don't think Bill Gates could sleep at night if he were to pursue these people for $$ just so he can get into the $100Bs.

That said, fakes for show is a side show.. the luxury companies pursue it to the extent it's in their interest, knowing it also helps to promote the brand so that even if 1 in 100 of these fake buyers were to have money one day to buy the real, they would still make money.

Besides this, bashing fake manufacturors, buyers, *ahem* China - we all have our go-to whipping boys .. what is less clear is the psychological mechanism behind this.
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      03-11-2014, 04:33 AM   #145
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What is weird is paying say $9000 (out of the £10k cost price) just to have Rolex painted on the watch face. It doesn't tell the time any better, they are nice enough looking watches but there are plenty of good looking watches to choose from that are just as well made, reliable and sensibly priced. It would grieve me too much to buy any designer item (not just watches) knowing that so little of the cost goes on the actual item itself. I guess if you are into watches it must make sense, God knows I've blown enough money on cars over the years.
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      03-11-2014, 01:24 PM   #146
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Quote:
Originally Posted by RR-NYC View Post
Wrong. They are not the same and if you worked in pharma you would know this 100%. Their adverse event profile aren't even the same

I too worked for a pharma company (a little $56B company called Pfizer) before moving into Medical device. The only thing a generic pharmaceutical company needs to guarantee is the active ingredient is the same. Everything else: stabilizers, drug delivery, and mechanism of action, metabolism are not regulated.

Your argument as to why you would buy it is not the point of the argument or the thread. Based on your posts, you would buy a BMW M3 regardless whether it was made by BMW or someone else who has no regard for trademarks or patents that essentially is telling you it's the same

Like I said, we have nothing to argue.
Ok... enough with the internet chest thumping... I worked at McKesson which is the largest heathcare company in the USA. Fortune #14 and sales over $120B yearly... with generic drugs as the largest growth in profit.

Generic pharmaceuticals are equivalent to brand products for all its active properties, forms, dosages etc. and it is highly regulated. No one buys the brand product after the generic is available! I'm not a pharmacist so I can't speak to the actual differences between drugs.

We are way off topic...
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      03-11-2014, 02:06 PM   #147
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Quote:
Originally Posted by Z K
Quote:
Originally Posted by RR-NYC View Post
Wrong. They are not the same and if you worked in pharma you would know this 100%. Their adverse event profile aren't even the same

I too worked for a pharma company (a little $56B company called Pfizer) before moving into Medical device. The only thing a generic pharmaceutical company needs to guarantee is the active ingredient is the same. Everything else: stabilizers, drug delivery, and mechanism of action, metabolism are not regulated.

Your argument as to why you would buy it is not the point of the argument or the thread. Based on your posts, you would buy a BMW M3 regardless whether it was made by BMW or someone else who has no regard for trademarks or patents that essentially is telling you it's the same

Like I said, we have nothing to argue.
Ok... enough with the internet chest thumping... I worked at McKesson which is the largest heathcare company in the USA. Fortune #14 and sales over $120B yearly... with generic drugs as the largest growth in profit.

Generic pharmaceuticals are equivalent to brand products for all its active properties, forms, dosages etc. and it is highly regulated. No one buys the brand product after the generic is available! I'm not a pharmacist so I can't speak to the actual differences between drugs.

We are way off topic...
I don't want to get too far off topic but since when are generic drug manufacturers become "highly regulated"? Compared to what?

Generic manufacturers are immune to liability because it's assumed it's the same as the branded counterpart when it's not.

The only reason generic sales continue to be relevant is because of health insurance and formularies. Formulary or not, I only buy branded drugs and my scripts are DAW branded for my own health and well-being. Generic drugs are not the same thing and there is plenty of objective research done to prove it.
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      03-11-2014, 02:30 PM   #148
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Originally Posted by RR-NYC View Post
I don't want to get too far off topic but since when are generic drug manufacturers become "highly regulated"? Compared to what?

Generic manufacturers are immune to liability because it's assumed it's the same as the branded counterpart when it's not.

The only reason generic sales continue to be relevant is because of health insurance and formularies. Formulary or not, I only buy branded drugs and my scripts are DAW branded for my own health and well-being. Generic drugs are not the same thing and there is plenty of objective research done to prove it.
"All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs. And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name." Quoted from the FDA web site. I've seen a lot of generic products never make it to market and approvals get yanked.

Of course generics are needed. The costs are much less than the branded drugs. Customers save money in getting the same products. And in the case of "authorized generics", they are even made by the same companies who make the branded product and is essentially the same product!
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      03-11-2014, 03:23 PM   #149
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Quote:
Originally Posted by Z K View Post
"All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs. And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name." Quoted from the FDA web site. I've seen a lot of generic products never make it to market and approvals get yanked.

Of course generics are needed. The costs are much less than the branded drugs. Customers save money in getting the same products. And in the case of "authorized generics", they are even made by the same companies who make the branded product and is essentially the same product!
+1 refusing to use generics is something I see from drug abusers who need to sell their meds on the street no real other reason to spend more for the same chemical entity. Its not the same as a knock of soda or something its a chemical stucture, if it has the same one it is the same thing.
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      03-11-2014, 07:25 PM   #150
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Quote:
Originally Posted by Z K View Post
"All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs. And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name." Quoted from the FDA web site. I've seen a lot of generic products never make it to market and approvals get yanked.

Of course generics are needed. The costs are much less than the branded drugs. Customers save money in getting the same products. And in the case of "authorized generics", they are even made by the same companies who make the branded product and is essentially the same product!
"Essential similarity" or bioequivalence is the only requirement the FDA has of generic manufacturers.

From the same page you quote: "Generics are not required to replicate the extensive clinical trials that have already been used in the development of the original, brand-name drug. These tests usually involve a few hundred to a few thousand patients. Since the safety and efficacy of the brand-name product has already been well established in clinical testing and frequently many years of patient use, it is scientifically unnecessary, and would be unethical, to require that such extensive testing be repeated in human subjects for each generic drug that a firm wishes to market. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner) to the pioneer drug."

So they are the same?

Here's what a 2 second search on NCBI provided (click the link to read the abstract):

Few publications compared the bioequivalence and efficacy of brand-name and generic psychoactive drugs. Those that were identified revealed differences in the efficacy and tolerability of brand-name and generic psychoactive drugs that had not been noted in the original bioequivalence studies.

There were no significant differences in overall tolerance (GSRS) between treatment groups. However, for subscale abdominal pain, patients using generic had a significantly higher mean GSRS score at week 4

To conclude... the patient had a fainting spell in his apartment, after which his blood pressure was found to be 220/120 mm Hg. Medication compliance did not appear to be an issue, but the same “family” physician realized that the patient had been switched to a generic ($30.25/mo v. $36.56/mo for the brand medication). The original brand was immediately restored, and 2 days later blood pressure was back down to 150/90 mm Hg. My father subsequently died from a dissected aorta, a well-known complication of high blood pressure.
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      03-11-2014, 07:28 PM   #151
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Can't argue with that
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      03-11-2014, 07:31 PM   #152
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What do you think bioequivalence means? If the same chemical compound is available at the same rate and amount failure of treatment has nothing to do with the product used.
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      03-11-2014, 07:33 PM   #153
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Originally Posted by 1MOREMOD View Post
+1 refusing to use generics is something I see from drug abusers who need to sell their meds on the street no real other reason to spend more for the same chemical entity. Its not the same as a knock of soda or something its a chemical stucture, if it has the same one it is the same thing.
You're a pharmacist and sincerely believe there is no difference between branded and generic?

Yeah, I abuse my Z-paks and hawk them on the street for those who have bronchitis.

Unfortunately, the FDA requirement for generics will soon blow up in their face as it has for many other fast-tracked approvals. Teva, the largest generic manufacturer in the world has a significant;y lower market share in their home country of Israel in comparison to the US. Do you know why? Here's a hint: It's not because of formulary issues
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      03-11-2014, 07:55 PM   #154
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Yes there is no difference, not a belief. If you start talking about counterfeit and unregulated drugs coming out of other countries they could be suspect. It is a chemical compound, if it has that in it and is bioevquivalent, what is required, yes it is the same. You give me 100 percent pure cocaine or any other compound it doesn't matter what name you call it if its measured out to the same amount it does the same thing. Any variation in reaction is due to individual personal variance.
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