Bioequivalence and Bioavailability Forum • Risk assessment

Risk assessment [BE/BA News]

posted by Helmut – Vienna, Austria, 2014-09-24 05:34 (3875 d 17:44 ago) – Posting: # 13561
Views: 14,604

Hi Ohlbe,

❝ That's all very fine for efficacy. But what about safety ?

That’s not really covered in the paper since the authors explored only bioinequivalence at the lower end (T/R 70%) of 400 mg. However, higher IR strengths of 600, 650, and 800 mg (CR 1,000 mg) are on the European market; note that 400/0.7 < 600. Above 400 mg the PK is less than dose proportional. The maximum daily dose is 2,400 mg. In the Biowaiver Monograph the risk was assessed as being low.

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Complete thread:

Article: BE-criteria too strict sometimes? Helmut 2014-09-23 12:39 [BE/BA News]
- Article: BE-criteria too strict sometimes? Ohlbe 2014-09-23 22:20
  - Risk assessmentHelmut 2014-09-24 03:34
    - Risk assessment Ohlbe 2014-09-24 10:22
      - Risk assessment nobody 2014-09-30 17:59
        
        Risk assessment Helmut 2014-10-01 13:02
        
        Risk assessment nobody 2014-10-01 13:32
- Are all men born equal? ElMaestro 2014-09-24 11:20
  - Article: BE-criteria too strict sometimes? felipeberlinski 2014-09-24 18:47
  - Some animals are more equal than others Helmut 2014-09-24 19:14
    - Some animals are more equal than others nobody 2014-09-24 20:32
    - Some animals are more equal than others Lucas 2014-10-14 17:02
      - Some animals are more equal than others Helmut 2014-10-14 21:15
        
        Some animals are more equal than others Lucas 2014-10-14 22:25
        
        Some animals are more equal than others Helmut 2014-10-15 03:20