Prior
knowledge was successfully used to support the clinical trial
applications of two small interfering RNA (siRNA) investigational
medicinal products (IMPs). A comparative, risk-based approach was
used to introduce supportive stability data from three other siRNA
IMPs to establish an initial 36 month drug product shelf life. The
structuring of supportive data from other clinical programs into Module
3 Quality of the Common Technical Document and response from health
authorities is additionally presented.
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