Indian pharma company falsified clinical data to get FDA approvals

[CanadianMalodu]

23 minutes ago, Jatka Bandi said:

Mari daniki taggatte allegations vestunte, pakkodu cheyatleda ani enduku arguments? Oho, Indian population size cheppukuni tappinchukuntaru kada. Got it.

India needs a systemic tear down and rebuild in all levels of governments with more decentralization.  I don't know when and how that happens. Until then this is how it is going to be. 

[Flush]

8 hours ago, DonnyStrumpet said:

In falsifying domain, India is going to new heights…..everyday 

#1 in world 

[Flush]

7 hours ago, MACH said:

Fekus antava manam

We all are KA Paul followers 

[Bendapudi_english]

9 hours ago, DonnyStrumpet said:

Holy Molly…..
 

https://www.thehindu.com/news/national/fda-uncovers-significant-data-falsification-by-indian-company-rejects-all-studies/article69416431.ece/amp/

Oh Indian companies clinicals kuda chesthaya ani amayakam ga aduguthuna Desi citizens.

[CanadianMalodu]

Just now, Bendapudi_english said:

Oh Indian companies clinicals kuda chesthaya ani amayakam ga aduguthuna Desi citizens.

It's not clinical trials in a strict sense. It's just bio equivalence studies.

[yslokesh]

13 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"

 

Yera malli ee AI sh it start cheesaava?

[yslokesh]

13 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"

 

Naaku yela thelusthindhu antaava?

LOL..

Bapatla looni Pentecoastal Church lo Telugu ki manam every day vaade telugu ki difference vuntadhi kadha, atlaage AI generated non-sense kooda easy gaa thelisipothadhi

[CanadianMalodu]

1 minute ago, yslokesh said:

Yera malli ee AI sh it start cheesaava?

Ee koodi brain ki English raadhu kadha. Alane anipisthadhi. Tappu ledhu.lol.

[CanadianMalodu]

2 minutes ago, yslokesh said:

Naaku yela thelusthindhu antaava?

LOL..

Bapatla looni Pentecoastal Church lo Telugu ki manam every day vaade telugu ki difference vuntadhi kadha, atlaage AI generated non-sense kooda easy gaa thelisipothadhi

Nee English skills tho neeku US visa icharu ante goppa vishyam ee. Ee DB lo ee bapathu bane unnaru. TOEFL entha vachindhi enti?

 

[yslokesh]

Just now, CanadianMalodu said:

Ee koodi brain ki English raadhu kadha. Alane anipisthadhi. Tappu ledhu.lol.

Haha, Vijayawada looni Pezzonipeta Church lo chebutaaru:

Daivajanulaara… vinandi

Devuni vaakku vinudi

Yehova mee koraku putti vunnaadu, meeru kallu vippi choodudi

[CanadianMalodu]

Just now, yslokesh said:

Haha, Vijayawada looni Pezzonipeta Church lo chebutaaru:

Daivajanulaara… vinandi

Devuni vaakku vinudi

Yehova mee koraku putti vunnaadu, meeru kallu vippi choodudi

Enti Nuvvu roju church kooda velthav enti? Lol. English ee anukunna, Telugu kooda Bible patanam chesi nerchukunnava, enti?

[DonnyStrumpet]

7 hours ago, CanadianMalodu said:

It's not clinical trials in a strict sense. It's just bio equivalence studies.

Who said bio equivalence studies are not part of clinical trials? It studies the difference in absorption of genetic and parent drug in subjects. 

[yslokesh]

4 minutes ago, CanadianMalodu said:

Enti Nuvvu roju church kooda velthav enti? Lol. English ee anukunna, Telugu kooda Bible patanam chesi nerchukunnava, enti?

Neevu yekkuvaga AI vaadamaakudi…

Yeshivah mimmalanu kshaminchadu… Ardham cheesukonudi

[DonnyStrumpet]

9 hours ago, CanadianMalodu said:

India needs a systemic tear down and rebuild in all levels of governments with more decentralization.  I don't know when and how that happens. Until then this is how it is going to be. 

I don’t see that happening for next 3 decades atleast. Nibbas and nibbis are the worst generation of Indians. They have no common sense. I mean literally about anything. 

[CanadianMalodu]

8 minutes ago, DonnyStrumpet said:

Who said bio equivalence studies are not part of clinical trials? It studies the difference in absorption of genetic and parent drug in subjects. 

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 (COVID Vax is an exception).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.