Drug manufacture

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Tero
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Re: Drug manufacture

Post by Tero » Mon Jan 20, 2020 10:15 pm

If the innovator changes the dose, they already have the new dose test runs done and the entire process validated. That is not announced. The generic maker will have validated the wrong dose, will need to scrap all stored product and start over. A new dose of the same product will take 6 months or more to change over and validate.

The paperwork and lab tests are nearly identical, just they all have to be done again. 6 month stability studies take...6 months!
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Re: Drug manufacture

Post by Tero » Mon Jan 20, 2020 10:48 pm

There is also the issue of total supply. Suppose the generic maker intends to make half the world supply. That leaves the innovator to make half. Since the number of patients does not change, the innovator can double the price. Some insurance companies will cover that.
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If you don't eat your meat, you can't have any pudding!
How can you have any pudding if you don't eat your meat?
You! Yes! You behind the bike sheds! Stand still, laddie!

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Re: Drug manufacture

Post by Svartalf » Mon Jan 20, 2020 11:16 pm

I must admit that for one who eats as many pills as I do, daily, I'm remarkably unaware of the workings and economy of Big Pharma.
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Re: Drug manufacture

Post by Tero » Mon Jan 20, 2020 11:23 pm

All in a day's work for your bureaucrsts. FDA/EU drugs have no more than 0.25% of impurities. Most of the impurities are also known and characterized.
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If you don't eat your meat, you can't have any pudding!
How can you have any pudding if you don't eat your meat?
You! Yes! You behind the bike sheds! Stand still, laddie!

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Re: Drug manufacture

Post by Tero » Fri Jan 24, 2020 3:57 am

Insys chief to jail
https://www.npr.org/2020/01/23/79897330 ... in-opioid-
The product is a fentanyl product for cancer patients but was given for "back pain."
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If you don't eat your meat, you can't have any pudding!
How can you have any pudding if you don't eat your meat?
You! Yes! You behind the bike sheds! Stand still, laddie!

Dominus vo-bisque'em Et cum spear a tu-tu, oh!

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Re: Drug manufacture

Post by Tero » Sat Feb 08, 2020 1:14 pm

This drug is new, under patent, and for some 20 000 patients in US
All drugs for that kind of group are going to be expensive
https://www.fda.gov/news-events/press-a ... c-fibrosis

Unlike many for rare diseases, this is an oral drug, a pill
https://www.rxlist.com/trikafta-drug.htm#description
https://esapolitics.blogspot.com

If you don't eat your meat, you can't have any pudding!
How can you have any pudding if you don't eat your meat?
You! Yes! You behind the bike sheds! Stand still, laddie!

Dominus vo-bisque'em Et cum spear a tu-tu, oh!

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Re: Drug manufacture

Post by Tero » Mon Feb 17, 2020 11:40 pm

The top insulin manufacturers are Eli Lilly and Company, Novo Nordisk and Sanofi. Together, they control 96% of insulin by volume worldwide — and can choose to raise prices when they want to.

https://www.npr.org/sections/goatsandso ... -the-price
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If you don't eat your meat, you can't have any pudding!
How can you have any pudding if you don't eat your meat?
You! Yes! You behind the bike sheds! Stand still, laddie!

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Re: Drug manufacture

Post by Cunt » Tue Feb 18, 2020 1:37 am

Tero wrote:
Sat Feb 08, 2020 1:14 pm
This drug is new, under patent, and for some 20 000 patients in US
All drugs for that kind of group are going to be expensive
https://www.fda.gov/news-events/press-a ... c-fibrosis

Unlike many for rare diseases, this is an oral drug, a pill
https://www.rxlist.com/trikafta-drug.htm#description
Tero, I ask you to consider a 'cause' I have seen being promoted up this way.

Rare disease.

Anyway, you have such unique experience, that if you considered the problems they are trying to address, you would likely have a useful and unique thing or two to say about their work. (Rare Disease Foundation - Registered Canadian Charity #
819326224RR0001)

I toss them a few bucks now and then, I also wear and promote their gear (everyone loves orange!) but in this one post, you casually mention one of the terrible aspects of the rare disease reality for a lot of individuals.

Your understanding sounds deep, and different.
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I don't want to forget this enlightening quote by our prestigious and sage member...
Hermit wrote:
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Tero
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Re: Drug manufacture

Post by Tero » Tue Feb 18, 2020 2:52 am

Your socialism isn't taking care or rare diseases?
https://esapolitics.blogspot.com

If you don't eat your meat, you can't have any pudding!
How can you have any pudding if you don't eat your meat?
You! Yes! You behind the bike sheds! Stand still, laddie!

Dominus vo-bisque'em Et cum spear a tu-tu, oh!

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Re: Drug manufacture

Post by Cunt » Tue Feb 18, 2020 3:22 am

Tero wrote:
Tue Feb 18, 2020 2:52 am
Your socialism isn't taking care or rare diseases?
It's not real socialism.

From what I gather, there isn't a great response to the rare diseases here. It can take years to get a diagnosis. While there are well-trodden paths for someone dealing with diabetes, the same can't be said for rare.

Living in a remote part of Canada, more common things are sort of 'rare', which makes it a bit easier to see some of the frustrations.
Shit, Piss, Cock, Cunt, Motherfucker, Cocksucker and Tits.
-various artists

I don't want to forget this enlightening quote by our prestigious and sage member...
Hermit wrote:
Wed Nov 25, 2020 11:41 am
Trump supporters are fundamentally racist.

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Tero
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Re: Drug manufacture

Post by Tero » Tue Feb 18, 2020 3:35 am

Do you have to fly out of there for any healthcare? The hospital can't be very big.

We have a similar city on the prairie that has the typical hospital taking care of some 30 000 county residents (plus a few from next door counties)
Welcome to CCH

Columbus Community Hospital is an acute care facility, with both inpatient and outpatient services. We are a not-for-profit hospital dedicated to providing compassionate, accessible health care close to home and consist of over 670 employees and 280+ volunteers.

I only went there to Columbus once to see 3 whooping cranes in a marsh nearby.
https://esapolitics.blogspot.com

If you don't eat your meat, you can't have any pudding!
How can you have any pudding if you don't eat your meat?
You! Yes! You behind the bike sheds! Stand still, laddie!

Dominus vo-bisque'em Et cum spear a tu-tu, oh!

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Re: Drug manufacture

Post by Cunt » Tue Feb 18, 2020 4:07 am

Tero wrote:
Tue Feb 18, 2020 3:35 am
Do you have to fly out of there for any healthcare? The hospital can't be very big.

We have a similar city on the prairie that has the typical hospital taking care of some 30 000 county residents (plus a few from next door counties)
Welcome to CCH

Columbus Community Hospital is an acute care facility, with both inpatient and outpatient services. We are a not-for-profit hospital dedicated to providing compassionate, accessible health care close to home and consist of over 670 employees and 280+ volunteers.

I only went there to Columbus once to see 3 whooping cranes in a marsh nearby.
I get sandihill cranes, pelicans and the ptarmigans you have seen. This org is nation-wide though, not my community.

Yeah, we have to fly out for some healthcare. I've been out for imaging (though we are supposed to be getting a local crew to run ours) and I took my pup out for a big surgery, and a false alarm once each.

My life is pretty beautiful, but little Molly is getting on in years. (plus that misadventure with the sock)
(spoilered to protect the modesty of her)
Trigger Warning!!!1! :
Mollydog.png
Shit, Piss, Cock, Cunt, Motherfucker, Cocksucker and Tits.
-various artists

I don't want to forget this enlightening quote by our prestigious and sage member...
Hermit wrote:
Wed Nov 25, 2020 11:41 am
Trump supporters are fundamentally racist.

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Tero
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Re: Drug manufacture

Post by Tero » Thu Apr 02, 2020 12:21 am

https://esapolitics.blogspot.com

If you don't eat your meat, you can't have any pudding!
How can you have any pudding if you don't eat your meat?
You! Yes! You behind the bike sheds! Stand still, laddie!

Dominus vo-bisque'em Et cum spear a tu-tu, oh!

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Tero
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Re: Drug manufacture

Post by Tero » Tue Apr 21, 2020 9:37 pm

Reading a book about sulfa drugs. They made field hospitals possible in WWII etc. They were discovered and spread to UK and US just before the war, but the production remained in Germany
https://www.amazon.com/The-Demon-Under- ... 658&sr=8-1

There are very few books about the drug industry in the popular press. It grew out of the dye industry, and the first one in fact was dye as well. it made you a bit pink as well for a few days.

https://en.wikipedia.org/wiki/Prontosil

Penicillin joined it in time for US war effort and in all, was easier to make, with no chemical steps:
The challenge of mass-producing this drug was daunting. On March 14, 1942, the first patient was treated for streptococcal sepsis with US-made penicillin produced by Merck & Co. (they had very little then)

BIG GOVERNMENT stepped in and
https://en.wikipedia.org/wiki/War_Production_Board
made it:
The results of fermentation research on corn steep liquor at the Northern Regional Research Laboratory at Peoria, Illinois, allowed the United States to produce 2.3 million doses in time for the invasion of Normandy in the spring of 1944.
https://esapolitics.blogspot.com

If you don't eat your meat, you can't have any pudding!
How can you have any pudding if you don't eat your meat?
You! Yes! You behind the bike sheds! Stand still, laddie!

Dominus vo-bisque'em Et cum spear a tu-tu, oh!

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Tero
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Re: Drug manufacture

Post by Tero » Sat Mar 06, 2021 11:20 pm

2019 cancer drug
https://www.sciencemag.org/news/2019/10 ... treatments

https://www.theguardian.com/science/202 ... -medicines

Neither article states what class of compound. Or if it's injected. Not a barrier for cancer drugs.
https://esapolitics.blogspot.com

If you don't eat your meat, you can't have any pudding!
How can you have any pudding if you don't eat your meat?
You! Yes! You behind the bike sheds! Stand still, laddie!

Dominus vo-bisque'em Et cum spear a tu-tu, oh!

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