Bioequivalence and Bioavailability Forum • Incurred sample reanalysis

Incurred sample reanalysis [Regulatives / Guidelines]

posted by sarada06884 – India, 2013-04-09 14:22 (4436 d 17:38 ago) – Posting: # 10381
Views: 16,538

Hi Helmut,

Incurred sample reanalysis has been suggested by USFDA but I would like to debate on this topic.

How are ISR samples different from subject samples? The answer would be they are in vivo samples and the QCs are in vitro samples. ISR samples are meant for demonstrating assay reproducibility. Based on this now my concern would be:

When the whole validation has been done based on in vitro samples and when the results of these experiments have been accepted then why ISR again?
When Long Term Matrix Stability of the drug and metabolites are proven taking invitro samples is proven and when the stability of such experiment is accepted then why ISR again?
Even though the ISR samples are reanalysed they are analysed along with CCs and QCs which are invitro again!!!!
What if ISR fails?? probably they have to ascertain the cause and go for the development of the method again?????

Please give me your views

Regards
Srinivas

Complete thread:

Incurred sample reanalysissarada06884 2013-04-09 12:22 [Regulatives / Guidelines]
- Incurred sample reanalysis Ohlbe 2013-04-09 14:09
  - Incurred sample reanalysis The Outlaw Torn 2013-04-10 08:40
    - Clopidogrel Ohlbe 2013-04-10 10:34
      - Clopidogrel The Outlaw Torn 2013-04-10 11:31
        
        Lack of ISR / only 5% ISR in study with 656 samples Helmut 2013-04-22 17:01
        
        Lack of ISR / only 5% ISR in study with 656 samples ElMaestro 2013-04-22 18:56
        
        Lack of ISR / only 5% ISR in study with 656 samples Helmut 2013-04-22 19:35
        
        "Meth" - apologies ElMaestro 2013-04-22 20:03
        
        "Meth" - apologies The Outlaw Torn 2013-04-23 08:27
        
        "Meth" - apologies ElMaestro 2013-04-23 14:29
        
        "ISR" - apologies The Outlaw Torn 2013-04-24 07:44
        
        Repeat use ElMaestro 2013-04-24 11:08
        
        Repeat use Ohlbe 2013-04-24 11:41
        
        Repeat use ElMaestro 2013-04-24 13:45
        
        "ISR" – resolved Helmut 2013-09-20 21:50
        
        "ISR" – resolved Dr_Dan 2013-09-22 16:56
        
        Lack of ISR / only 5% ISR in study with 656 samples ElMaestro 2013-04-23 23:31
        
        Some more stuff Helmut 2013-04-24 02:08
        Lack of ISR / only 5% ISR in study with 656 samples nobody 2014-10-23 10:06