Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-11-24 13:58 CET (UTC+1h)
 
ElMaestro
Hero

Denmark,
2017-03-01 14:36

Posting: # 17117
Views: 1,031
 

 You can't make this stuff up [GxP / QC / QA]


I could be wrong, but…


Best regards,
ElMaestro

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.
nobody
Senior

2017-03-01 16:17

@ ElMaestro
Posting: # 17118
Views: 874
 

 You can't make this stuff up

"...to ensure passing system suitability results."

Validation is to show suitability for the intended purpose. Mission accomplished!

I never would have imagined to see erosion of all what we call "science" in such a short time...

Last night some idiot presented somewhere in the world a chronically ill person and her father into public to advocate "faster approval" of what-so-ever-idiot-calling-himself-a-scientist-has-pulled-out-of-his-axx as a drug by the FDA.

Kindest regards, nobody
Helmut
Hero
Homepage
Vienna, Austria,
2017-03-02 13:42

@ nobody
Posting: # 17119
Views: 804
 

 System suitability

» "...to ensure passing system suitability results."
»
» Validation is to show suitability for the intended purpose. Mission accomplished!

Generally system suitability could be performed to assess whether the system runs within its spec’s before an analytical run (CCs, QCs, unknowns). Examples: Injecting blank extracts to condition new columns, checking retention times, capacity factors, peak symmetry & resolution, tuning the detector, :blahblah:
Of course, a procedure must exist and followed. Limiting SS to a certain number of injections is not a good idea. Deleting out-of-spec’s results is stupid. Better is sumfink like:

“The system suitability test passes if – after corrective measures if necessary – n subsequent (!) injections fulfill criteria X, Y, Z.”


Fully agree to your other points. :-D
Didn’t Mr Trump say that for every new regulation two old ones have to be suspended? Lean state?

[image]Regards,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
nobody
Senior

2017-03-02 13:55

@ Helmut
Posting: # 17120
Views: 772
 

 System suitability

sorry, forgot the IRONY tags... but you should know me by now (and my strange kind of comments) :-D

Kindest regards, nobody
jag009
Hero

NJ,
2017-03-02 19:46

@ nobody
Posting: # 17123
Views: 749
 

 System suitability

I once heard that a chinese company conducted a replicate study with n=24 and ran the stats as if it was a n=48 subject study... Not a joke...:confused:

John
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,495 Posts in 3,746 Threads, 1,085 registered users;
30 users online (1 registered, 29 guests).

The belief that there is only one truth and
that oneself is in possession of it,
seems to me the deepest root of all
that is evil in the world.    Max Born

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed