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General Medication Discussion This section is to be used for general medication discussion and other medications not broken out in their own respective forums.

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  #1  
Old 07-21-17, 03:15 PM
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Exclamation Generic - inspections by FDA For Quality

About 65% to 75% of generic drugs are manufactured in countries that I guarantee you would not want to live.

And it is profoundly sad that the FDA fails to check these facilities in what anyone would deem to be an appropriate time frame...for issues such as quality control and bioequivalency

As I stated in my first text on this topic, generic companies do their --own testing-- before they seek approval, and the results of their testing is ----not made public-----

Bioequivalency can vary plus or -20%…

**It is important to understand that it is the generic company that establishes and conducts their study

* you know that ---"confirmation bias"-- exists.....--profoundly--

Also, they keep secret bioequivalency of their product

If there is nothing to hide, why not open the books
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Old 07-21-17, 03:41 PM
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Re: Generic - inspections by FDA For Quality

Who is in charge?

Good luck finding that out.

If so, maybe we should visit in person with that person.
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Old 07-21-17, 04:15 PM
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Re: Generic - inspections by FDA For Quality

Concerning their tests, we simply have to take their word for it
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Old 07-21-17, 04:17 PM
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Re: Generic - inspections by FDA For Quality

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Originally Posted by wonderboy View Post
Concerning their tests, we simply have to take their word for it

No one is ever accountable. Really disgusting.
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Old 07-21-17, 04:44 PM
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Re: Generic - inspections by FDA For Quality

Yes it really is. And I do not understand why generic companies do not make their bioequivalency data available to the public
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Old 07-21-17, 04:57 PM
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Re: Generic - inspections by FDA For Quality

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Originally Posted by wonderboy View Post
Yes it really is. And I do not understand why generic companies do not make their bioequivalency data available to the public
It probably wouldn't be correct anyway. I have a problem with statistics as that they can be manipulated.
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Old 07-22-17, 08:26 AM
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Re: Generic - inspections by FDA For Quality

The irony is some doctors and pharmacists have the nerve to act like we are crazy for noticing differences in generic formulations of the same drug. I was never one to even believe it to be the case until the last two years dealing with my adderall.
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Old 08-11-17, 11:04 PM
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Exclamation Re: Generic - inspections by FDA For Quality

This issue (the fact that the FDA) does not have the resources to inspect many pharmaceutical manufacturing in remote countries.


Also, The fact that a generic company does not have to disclose their own
bioequivalence tests that THEY perform before receiving FDA approval for marketing

Talk about weak internal and external validity..
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Old 08-12-17, 08:03 PM
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Exclamation How Generic Companies are FDA approved

The most startling and upsetting fact about how a generic company is approved by the FDA is the entire process:

Take Adderall for example.

When a generic company decides it would like to manufacture Adderall, it must conduct bioequivalency testing.

The issue I have with this is that the testing is completed solely by the generic company, and the results are not available to the public, only to the FDA.

Why not allow the public to know what the test showed, and how --specifically-- was the test conducted.

Was their appropriate internal and external validity.

The entire process is flawed in my opinion. Just an opinion
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  #10  
Old 08-12-17, 09:14 PM
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Re: How Generic Companies are FDA approved

Quote:
Originally Posted by wonderboy View Post
The most startling and upsetting fact about how a generic company is approved by the FDA is the entire process:

Take Adderall for example.

When a generic company decides it would like to manufacture Adderall, it must conduct bioequivalency testing.

The issue I have with this is that the testing is completed solely by the generic company, and the results are not available to the public, only to the FDA.

Why not allow the public to know what the test showed, and how --specifically-- was the test conducted.

Was their appropriate internal and external validity.

The entire process is flawed in my opinion. Just an opinion
It is not just an opinion. Its the truth.

Asthma inhalers are the same way. I don't even know WHAT Pro-Air is but a big blobby mess that never sprays, so I get Ventolin. It works.

Xanax generic brands, only Greenstone actually work, who else knows what. But what exactly can we do about it? Frankly, it stews the hell out of me.
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  #11  
Old 08-12-17, 09:25 PM
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Re: How Generic Companies are FDA approved

And I miss the old Teva footballs. They were always so reliable and nice.
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