Drug manufacture

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Tero
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Re: Drug manufacture

Post by Tero » Sat May 18, 2019 9:54 am

I'm not buying the book!
https://www.npr.org/sections/health-sho ... -you-think
If the FDA suspects a Chinese generic, a more effective way than inspecting plants is to spot check more samples from the US distributor or buy samples from stores.

There appear to be no examples, just "...people on maintenance medications who are taking these drugs day in and day out. Those drugs may have toxic impurities. Those can build up in your liver, you may not know it, or you may be having side effects that you didn't think about before, and then you realize, "Wait a second I was switched to a different generic" or "I was switched from a brand to a generic."

That was all speculation.

If the journalist had money to fly to China, it would have been better spent getting drugs here and sending them to an analytical lab here. Each drug at approved stage has a known impurity profile.

If you take an injectable drug, the risk in generics is greater. Even sealed ampules get bacterial growth.
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Re: Drug manufacture

Post by Tero » Sat May 18, 2019 10:30 am

One area where generics fail is 12 hour formulas. The tablet does not dissolve at the slow rate. Some drugs also a pressed too hard to pills and take longer to dissolve in your gut. They all would have the right amount of drug per pill.
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Re: Drug manufacture

Post by Tero » Sun May 26, 2019 10:36 pm

Teva makes a good portion of your generics.
https://www.npr.org/2019/05/26/72717991 ... opioid-cas
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Re: Drug manufacture

Post by Svartalf » Sun May 26, 2019 11:34 pm

Actually most of mine are Mylan, I get Teva when I go to the Other pharmacy shop.
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Re: Drug manufacture

Post by Tero » Fri Jul 12, 2019 12:03 pm

This is novel: formulate an addiction treatment drug, which they invented, to make it more addictive!
https://www.npr.org/2019/07/11/74085694 ... settlement

The drug is effective if used supervised. Most European heroin addicts are on it. It is of some use in pain relief, and it does not really get you high.
https://en.m.wikipedia.org/wiki/Buprenorphine/naloxone
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Re: Drug manufacture

Post by Tero » Fri Jul 12, 2019 12:44 pm

Tero wrote:
Fri Jul 12, 2019 12:03 pm
This is novel: formulate an addiction treatment drug, which they invented, to make it more addictive!
https://www.npr.org/2019/07/11/74085694 ... settlement

The drug is effective if used supervised. Most European heroin addicts are on it. It is of some use in pain relief, and it does not really get you high.
https://en.m.wikipedia.org/wiki/Buprenorphine/naloxone
Deaths from Suboxone are a very small percentage of opiate deaths.
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Re: Drug manufacture

Post by Tero » Mon Jul 15, 2019 1:49 am

But for overseas inspections—due to complex logistics of visas and access to the plant—the FDA typically gives weeks or months of advance notice, allowing companies to fabricate critical aspects of their operations. The plants had drafted "internal memorandums and records directing employees to create falsified records in preparation for FDA regulatory inspections," Lal wrote back to senior officials at the FDA's Maryland headquarters.
https://www.newsweek.com/2019/07/19/bot ... 46934.html
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Re: Drug manufacture

Post by Tero » Fri Aug 23, 2019 1:37 am

Articles on the opiate crisis neglect to state the role of the DEA
https://www.npr.org/sections/health-sho ... ust-soared
The DEA is partly to blame as they have to approve the yearly amounts manufactured. They could have approved lesser amounts. Too much regulation?
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Re: Drug manufacture

Post by rainbow » Fri Aug 23, 2019 6:33 am

Tero wrote:
Fri Jul 12, 2019 12:03 pm
This is novel: formulate an addiction treatment drug, which they invented, to make it more addictive!
https://www.npr.org/2019/07/11/74085694 ... settlement

The drug is effective if used supervised. Most European heroin addicts are on it. It is of some use in pain relief, and it does not really get you high.
https://en.m.wikipedia.org/wiki/Buprenorphine/naloxone
It looks like the lawyers will make lots of money and kill any incentive for innovation, but why should they care?
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Re: Drug manufacture

Post by Tero » Fri Sep 13, 2019 10:41 pm

Companies that have public stock don't get to do this:
New York state Attorney General Letitia James says the family that owns Purdue Pharma, maker of the opioid Oxycontin, used Swiss bank accounts to transfer one billion dollars from the company to themselves.
https://www.npr.org/2019/09/13/76068888 ... -themselve

Purdue is now bankrupt
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Re: Drug manufacture

Post by Tero » Tue Oct 01, 2019 4:57 pm

C8F2202C-8E43-472E-A96B-94DF7CD7A0BF.jpeg
Even in the Obama era the gov't was accused of too much regulation. The DEA allowed businesses to take the risk. Poorly monitoring pharmacies.
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Re: Drug manufacture

Post by Sean Hayden » Thu Jan 09, 2020 2:29 pm

Really, good. How much harder would you like to make it for people to get drugs? You already can't get a lot without providing a valid ID. There's a db being kept for every time you buy cold medicine ffs.
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Re: Drug manufacture

Post by Sean Hayden » Fri Jan 10, 2020 3:19 am

I feel I should provide more relevant examples than a valid id :lol: That's just something that always bugs me. :biggrin:

Anyway, regulations have been proposed that include everything from requiring regular drug testing to adding patients to databases to monitor who all is taking what. Of course this data is available already, the difference would be in how it is requested, acquired, and the purpose of acquiring it.

--//--

I don't think it's a big deal to suppose that regulations vary in their usefulness across industries and according to our goals.
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Re: Drug manufacture

Post by Tero » Mon Jan 20, 2020 9:28 pm

Name brand maker changes dosage (with almost the same effect, not better) to confuse generic maker and slow down validation of product.
https://www.kios.org/post/patients-stil ... te-generic
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Re: Drug manufacture

Post by Svartalf » Mon Jan 20, 2020 9:59 pm

confusing generic makers, I can get, but what's the matter with validating the product? You'd think they'd want product validated fast so it can get sooner on the market.... What did I miss?
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