PharmPK Discussion - Stability studies for ANVISA submission

• On 19 Jan 2012 at 17:28:17, narasimha reddy (r.nara.simha.reddy123.at.gmail.com) sent the message
  

  
  Hi all,
  
  I am currently working on the Bio-analytical method development and
  validation for a molecule intend for ANVISA submission.
  
  Regarding stability studies, we need to follow the same stability
  studies criteria as we follow for the US FDA/EMEA submission or we need
  to modify the routine drug stability testing during 3 freezing-thawing
  cycles and Long term stability study.
  
  

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• On 2 Feb 2012 at 11:03:25, "DR.GUNA SAKARAN" (drgunasakaran.aaa.gmail.com) sent the message
  

  
  Dear Mr.Reddy,
  
  As per ANVISA Recommendation, the stability studies should involve at
  least:
  
  a. The investigation of the drug stability in the matrix at room
  temperature (i.e., the stability of the drug before the sample analysis
  process). This study aims at deciding whether the addition of a
  stabilizer is required during the sample collection process.
  
  b. Drug stability in the final extraction solution during a period
  estimated for the maximum analysis period, varying from 24 to 48 hours
  for the automatic injection.
  
  c. Drug stability during 3 (or more) freezing-thawing cycles (one cycle
  being extended as, for instance, thawing the sample, leave at room
  temperature for 1 hour and freeze it for at least 24 hours).
  
  d. Long-term drug stability study in frozen samples.
  
  Regards,
  
  Dr.S.Gunasakaran, MD
  Head - Clinical Research & Medical Affairs,
  Azidus Laboratories Ltd, CRO.
  Clinical Research Forum http://www.clinicalresearchsociety.org/forum/
  
  

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