Monday, 20 February 2012

Sample Quality Overall Summary

I am sure that, many of you may be interested to take a look at complete NDA/ANDA/Dossier/ASMF. Since, they contain confidential information, no company would like to share it in public domain. But guys! you could check out sample Quality Overall Summary (part of Module-2) of an ANDA submission. FDA has posted samples of Quality overall summary (QOS) in its website the links of which are provided below-

Module 2- It is part of  NDA/ANDA/Dossier/DMF/ASMF, where the summaries of Modules-3,4,5 are presented. It could  be correlated to an abstract of research article or trailer of a movie! The module-2 (Common Technical Document Summaries) consist of the following sections-

2.1 Common Technical Document Table of Contents (Modules 2-5)
2.2 CTD Introduction
2.3 Quality Overall Summary
2.4 Nonclinical Overview
2.5 Clinical Overview
2.6 Nonclinical Written and Tabulated Summaries
  • Pharmacology
  • Pharmacokinetics
  • Toxicology
2.7 Clinical Summary
  • Biopharmaceutic Studies and Associated Analytical Methods
  • Clinical Pharmacology Studies
  • Clinical Efficacy
  • Clinical Safety
  • Literature References
  • Synopses of Individual Studies

 As discussed by me earlier, you need to refer -M4 GuidelineM4Q GuidelineM4S GuidelineM4E Guideline to file a  NDA/ANDA/Dossier/DMF/ASMF in CTD format.

Reference-M4 Guideline

Keywords - Sample Quality Overall Summary, Module-2, M4 Guideline, FDA.


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