Indian pharma company falsified clinical data to get FDA approvals

[CanadianMalodu]

4 minutes ago, yslokesh said:

Neevu yekkuvaga AI vaadamaakudi…

Yeshivah mimmalanu kshaminchadu… Ardham cheesukonudi

Nuvvu vaduthava enti? Inthaki TOFEL rasava adhi kooda rayinchava 🤔?

[DonnyStrumpet]

3 minutes ago, CanadianMalodu said:

Which is why I said in a strict sense. Clinical trials have different end points. They deal with safety establishment first, and then  dose optimization and efficacy. These will go on for about some 8-10 years before a regulatory filing happens. The trial design itself will be different from as simple as a open label PK trial to complex multi center studies across countries. These last upto months.

Bio-equivalence is a very simplistic one in that sense. You do a 2X2 format (seq, period) for a cross over once with a brand drug and once with generic (Ctrl vs test) in about less than 20 subjects and run for serum conc. That's it. It's very simple. 

Yes. The framework and duration might be different than phase 1,2 and 3 type of trails. Nonetheless, even bioequi studies still have a pivotal relevance in drug approval process. I don’t think it can be downplayed in any shape or form. 

[yslokesh]

14 hours ago, CanadianMalodu said:

This is NOT new NOR is only happening in India. You are seeing them in India because they're being "outsourced" to India and Indian CROs are constantly under pressure to get "favorable" results as customers want that. 

A generic Equivalence should be between 80-125% compared to the brand. When the results are falling in the lower side, typically happens when the drug molecule has poor absorption, inter person variability, subjects drop offs, so they spike the "samples" with certain amounts of Active ingredients (API) to get a "passable" in the chromatograph data. FDA and EU authorities find these when they inspect facilities or review their " raw data"

 

Neevu nizamain devuni biddavi… neeku paralokam lo vunna Prabhuvu daya yellappudu vundunu…

neeku real estate, finance, stock market, Pharma, history, Geography, civics, economics anniti meedha intha gnaanam vundutam valla neevu Yesu Bidda gaa pariganimpadunu..

andhuvalanane neevu Devudi Bidda gaa gurthimpu pondhitivi..

Yehova neeku marintha gnaanam ivvu gaaka.

 

[CanadianMalodu]

9 minutes ago, DonnyStrumpet said:

Yes. The framework and duration might be different than phase 1,2 and 3 type of trails. Nonetheless, even bioequi studies still have a pivotal relevance in drug approval process. I don’t think it can be downplayed in any shape or form. 

It's relatively way easier to have bio-equivalence study done. You could have one done in a span of two months. All you need is healthy volunteers, who are plenty and cheap to come by in India. Hence the outsourcing push. 

This is very very different from Clinical trials which get way more complex. Where did I down play it? By downplaying if you mean the ease of doing it, yes it's way easier. You needs show string budget (under 10 lakhs) for a bio-equivalence trial. 

[CanadianMalodu]

11 minutes ago, yslokesh said:

Neevu nizamain devuni biddavi… neeku paralokam lo vunna Prabhuvu daya yellappudu vundunu…

neeku real estate, finance, stock market, Pharma, history, Geography, civics, economics anniti meedha intha gnaanam vundutam valla neevu Yesu Bidda gaa pariganimpadunu..

andhuvalanane neevu Devudi Bidda gaa gurthimpu pondhitivi..

Yehova neeku marintha gnaanam ivvu gaaka.

 

Naaku gnanam ivvadam emo kani, neeku matram Telugu bane neerpinchadu ,lol.

[Bhavarogi]

18 hours ago, CanadianMalodu said:

This is NOT new NOR is only happening in India. You are seeing them in India because they're being "outsourced" to India and Indian CROs are constantly under pressure to get "favorable" results as customers want that. 

A generic Equivalence should be between 80-125% compared to the brand. When the results are falling in the lower side, typically happens when the drug molecule has poor absorption, inter person variability, subjects drop offs, so they spike the "samples" with certain amounts of Active ingredients (API) to get a "passable" in the chromatograph data. FDA and EU authorities find these when they inspect facilities or review their " raw data"

 

this statement appears sound.....but doesn`t make any sense. you`re connecting poor absorption , inter person variability to chromatograph to raw data.

[CanadianMalodu]

26 minutes ago, Bhavarogi said:

this statement appears sound.....but doesn`t make any sense. you`re connecting poor absorption , inter person variability to chromatograph to raw data.

I'm not saying these are interrelated. Anyone of these can contribute to "not so happy" results. 

That's when serum samples from the subjects of the bio-equivalence trials get "spiked" with drug API. So that the chromatograph will give you the results you "want".