Spring Intro 2023

03/03/2023

Module 4 contains information on the nonclinical (pharmacological, pharmacokinetic and toxicological) evaluation of the drug/biologic substance and product. This information is typically provided in the form of study reports and publications. This module is the first thing I used to read so I could make up my own mind (before companies tried to pull the wool over my eyes!!)

29

Module 2.6 contains the tabular summaries and written summaries for Pharmacology, Pharmacokinetics and Toxicology. The primary purpose of these nonclinical written and tabular summaries is to provide a comprehensive “factual synopsis” of the data. The interpretation of the data, the clinical relevance of the findings and the implications for man should be addressed in the nonclinical overview – Module 2.4.

30