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We did BE on pravastatin tablets 80 mg almost two years back and
passed the study as per FDA requirement, but off late FDA is asking
to reanalyse the plasma samples as the method which was adopted
earlier was not separating Pravastatin from its major metabolite ie
3' alpha pravastatin.
I think all the generic companies follwed the same bioanalytical
methods. Upon reanalysis with a new method our study is showing to be
failing for Cmax in fasting and AUC in fed condition and CV almost
doubled (more than 40%) than the original results.
Do any one have some light to through on this issue.
Manager Product Development
InvaGen Pharmaceutical Inc.
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