Of the FDA Science Forum 2006, which took place in Washington on 18-20
April 2006, two contributions concerning dissolution testing have been
published:
Studies of Variability in Dissolution Testing with Apparatus 2
Repeatability and reproducibility in dissolution testing have been a
critical point for many years. This study published by FDA
representatives shows that in 70% of all cases, variability of results was
due to the tablets themselves, in 25%, it depended on the dissolution
equipment and in 5% of the cases, the fault lay with the lab staff.
Click here
to read the abstract.
USP Apparatus 4 Dissolution Profile Prednisone Tablets Lot P
Here, USP employees checked if USP Prednisone Tablets Lot P can be used
in flow-through cell apparatus. The summary points out that, at the very beginning of
release testing, it can be critical to obtain reproducible test results.
Click here
to read the summary.
Besides, the FDA published a position paper of the US-American Generic
Pharmaceutical Association (GPhA) titled <GPhA Proposed Pathway for Quality by Design Dissolution Testing
and Setting Specifications for Generic Drugs>. This
position paper deals with the difficulties faced by generics manufacturers
in the context of dissolution testing.
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