Bioequivalence and Bioavailability Forum

Repeat use [Regulatives / Guidelines]

posted by Ohlbe – France, 2013-04-24 13:41 (4811 d 19:43 ago) – Posting: # 10486
Views: 16,804

Hi El Maestro,

❝ If there is any concern it has probably been caught by the pharmacovigilance system.

I doubt it, unless it is really a big, big problem... The substitution of the reference product by the generic is made by the pharmacist selling the drug to the patient. The prescriber usually doesn't even know which generic was given to his patient. 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

Complete thread:

• Incurred sample reanalysis sarada06884 2013-04-09 12:22 
  • 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 useOhlbe 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