Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals

1 GUIDELINE ON THE NEED FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS 1. INTRODUCTION The objectives of carcinogenicity studies are to identify a tumorigenic potential in animals and to assess the relevant risk in humans. Any cause for concern derived... More

1
GUIDELINE ON THE NEED FOR CARCINOGENICITY STUDIES OF
PHARMACEUTICALS
1.
INTRODUCTION
The objectives of carcinogenicity studies are to identify a tumorigenic potential in
animals and to assess the relevant risk in humans.
Any cause for concern derived
from laboratory investigations, animal toxicology studies, and data in humans may
lead to a need for carcinogenicity studies.
The practice of requiring carcinogenicity
studies in rodents was instituted for pharmaceuticals that were expected to be
administered regularly over a substantial part of a patient s lifetime.
The design and
interpretation of the results from these studies preceded much of the available
current technology to test for genotoxic potential and the more recent advances in
technologies to assess systemic exposure.
These studies also preceded our current
understanding of tumorigenesis with non-genotoxic agents.
Results from genotoxicity
studies, toxicokinetics, and mechanistic studies can now be routinely applied Less