Potential to Simplify the Writing of Submission Documents : Evaluation of Publicly Available Module 2 Documents in Drug Submissions from Different Pharmaceutical Companies
Forstén, Ronja (2021)
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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 preparation of these publicly available documents. The documents were compared, their relation to the sponsors was analyzed, and the results were compared to the CTD guidelines for module 2 documents to investigate how well the guideline was followed.