Bioequivalence and Bioavailability Forum

Speculations [BE/BA News]

posted by Helmut  – Vienna, Austria, 2014-12-07 15:41 (3418 d 00:58 ago) – Posting: # 14001
Views: 19,339

Hi ElMaestro,

❝ assuming fraud has truly been committed at GVK Bio what would you think is the root cause?

Duno. Greed? Though saving a few rupees seems to be outright absurd. These ECGs were part of the post study exams. Did they want to avoid complications – what if an ECG shows abnormalities? Hey, that’s a normal one – let’s use it for other volunteers! GVK claimed that these ECGs do not invalidate the outcome of BE-studies. But that’s not the point. It shows non-compliance with the principles of GCP – which casts a dim light on other parts of the studies as well. Remember the credo of GxP-inspectors “if you didn’t write it down, you didn’t do it”. Fraudsters have learned this lesson. GVK proudly stated on their  website:

GVK Biosciences, Asia’s leading Contract Research Organization today announced that its Ahme­dabad Clinical Pharmacology Unit successfully cleared the US FDA Audit with zero 483s/ observations from the agency.
The Ahmedabad success comes on the heels of regulatory joint inspection by FDA, ANSM (France), AGES (Austria) and WHO, of the GVK BIO Hyderabad facility. This inspection was the first joint inspection of a CRO by the four agencies. GVK BIO received zero 483s by FDA in this joint inspection.

Nothing was written down. Bad luck for the FDA. Ask ANSM for their report…

Henning Blume was once invited by an Indian CRO. He asked how many studies failed in the past. The answer was “zero”. He replied “That’s an amazing percentage. Probably you should teach us how to design and perform BE-studies. Our failure rate is much higher.”

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Bioequivalence in prime time TV news Dr_Dan 2014-12-05 08:42 
  • Bioequivalence in prime time TV news nobody 2014-12-05 08:51
    • Bioequivalence in prime time TV news Ohlbe 2014-12-05 14:10
      • Bioequivalence in prime time TV news nobody 2014-12-05 16:56
        • Bioequivalence in prime time TV news Helmut 2014-12-05 17:24
      • Bioequivalence in prime time TV news nobody 2015-01-23 17:08
  • If you know German… Helmut 2014-12-05 13:27
    • If you know German… nobody 2014-12-05 14:20
      • Monitoring CROs Helmut 2014-12-05 17:49
        • Monitoring CROs nobody 2014-12-05 18:02
          • Ethics? Helmut 2014-12-05 22:54
            • Ethics? nobody 2014-12-06 14:23
        • Monitoring CROs ElMaestro 2014-12-06 22:10
          • Monitoring CROs Helmut 2014-12-07 14:08
            • Monitoring CROs nobody 2014-12-12 10:51
              • Inspectors ≠ teachers (rather = examiners) Helmut 2014-12-12 14:41
  • RCA ElMaestro 2014-12-07 01:06
    • SpeculationsHelmut 2014-12-07 14:41
      • Speculations nobody 2014-12-07 17:31
      • Speculations ElMaestro 2014-12-07 20:20