Bioequivalence and Bioavailability Forum • Deficiency response

Deficiency response [Regulatives / Guidelines]

posted by kamblpa2 – 2012-08-13 12:33 (5070 d 00:50 ago) – Posting: # 9056
Views: 6,180

Dear All,

Kindly provide your inputs for the response for the following deficiency received from France Regulatory agency,

i) As per the current EMEA guideline 2012, Incurred sample reanalysis was not performed.

Since the study was conducted in year 2007, that time ISR was not given in the guideline.

We need to provide the justification to avoid rejection from authority

Thanks

Complete thread:

Deficiency responsekamblpa2 2012-08-13 10:33
- Deficiency response Ohlbe 2012-08-14 00:17
- CMDh reminder Ohlbe 2012-09-25 19:01
  - CMDh reminder ElMaestro 2012-09-25 20:21
    - CMDh reminder Ohlbe 2012-09-25 22:06
      - CMDh reminder Dr_Dan 2012-09-26 11:35
        
        Long-term storage samples? Helmut 2012-09-26 14:48
        CMDh reminder ElMaestro 2012-09-26 17:30
        
        CMDh reminder Ohlbe 2012-09-27 23:15
        
        CMDh reminder Dr_Dan 2012-09-28 15:32
        
        CMDh reminder ElMaestro 2012-09-28 17:04
        
        90%+ off-topic Helmut 2012-09-28 17:48
        
        90%+ off-topic ElMaestro 2012-09-29 09:30