Bioequivalence and Bioavailability Forum • Repeat use

Repeat use [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2013-04-24 15:45 (4420 d 04:15 ago) – Posting: # 10488
Views: 14,541

Hi Ohlbe,

❝ I doubt it (...) If, by some sort of a miracle, he decides to make a pharmacovigilance declaration, to which product will he assign the AE?

❝

❝ Sorry for being pessimistic, but I don't have much trust in the pharmacovigilance of generics :-(

I agree in the sense that the PV systems -and here I do not mean any applicant's own system but the EU-wide and possibly ROW-wide systems- do not pick up issues with great sensitivity and they rely on active reporting reporting. Only the serious stuff gets reported.
For a repeat use MRP the applicant will be able to refer to something like 1.000.000 patient years of treatment experience and garnish that with info about reported numbers of deaths or people who contracted syphilis while being treated with the drug etc etc. I think that counts for something although it is not formalised.

In a nutshell I would rather take a product that has 1.000.000 or whatever patient years in the luggage and no ISR rather than taking a product with acceptable ISR for which the total human exposure is a 2,2,2-BE trial in Hevo's totalling 1 day of exposure with one unit dose for the Test.

—
Pass or fail!
ElMaestro

Complete thread:

Incurred sample reanalysis sarada06884 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 useElMaestro 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