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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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As per ANVISA Recommendation, the stability studies should involve at
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.
Head - Clinical Research & Medical Affairs,
Azidus Laboratories Ltd, CRO.
Clinical Research Forum http://www.clinicalresearchsociety.org/forum/
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