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I am Shripad Chitnis , Student of MS - Pharmaceutical Sciences,
University of Rhode Island (Kingston) USA. We are carrying out a long
term stability study experiment for a drug in plasma matrix in our
laboratory. We are planning to follow the FDA guidelines for the
same. However, even after going through CDER Guidelines
"Bioanalytical Method Validation" 2001, we had a few questions:
1. What should be the analysis time interval for stability studies of
a drug in plasma
matrix if we plan to carry out the study for 6 months?
2. What should be the storage temperature for storing the samples
through out the experiment? (-70 degree/ -20 degrees)
3. Am I suppose to prepare NEW CALIBRATORS at the day of analysis
every time or I can use the same calibrators through out the studies.
Alternatively, can we use the calibration curve prepared on Day 0
(before starting the study)?
4. In case, I am analyzing samples 6 times i.e. after every 1 month
over a period of 6 months (Study period 6 month), am I suppose to
store the sample back after I take the aliquot or is it preferable
to prepare 6 sets of samples of each concentration at the beginning
of the study so that I can use new aliquot each time.
Kindly, help me with above questions
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