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Potential to Simplify the Writing of Submission Documents : Evaluation of Publicly Available Module 2 Documents in Drug Submissions from Different Pharmaceutical Companies
The aim of this research project has been to consider whether the writing strategies for module 2.5 and 2.7 submission documents could be simplified and if any simplification suggestions could be implemented for the ...
Evaluation of release specifications for critical raw materials, drug substance and drug product in the production process of recombinant adeno-associated virus vectors
In gene therapy, adeno-associated virus (AAV) vectors have shown to be efficient vehicles for delivering the gene of interest to the target site. To date, there are three AAV-based biologicals approved by authorities; ...