- Requirements of each section of CTD module 3, considering reference guidelines of ICH and EU will be given
- Every CTD section of Module 3 will be explained based on your case study of chemically synthesized existing active substances
- Wherever required, basic terms used in the various
sections Like stereochemistry, polymorphism, hygroscopicity, mutagenicity, TTC etc will be discussed.
- Correlation of various CTD sections and possible deficiencies