DMF REVIEW

CONTENTS

  • 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
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