5.5.2 Chronic Toxicity (12 Months or Longer)

For drugs intended for use in humans for longer than six months, chronic toxicity testing under OECD 452 (rodent) or OECD 453 (combined chronic...

For drugs intended for use in humans for longer than six months, chronic toxicity testing under OECD 452 (rodent) or OECD 453 (combined chronic toxicity/carcinogenicity) extends dosing to twelve months or beyond, using larger groups of twenty males and twenty females, and incorporates satellite groups held for a recovery period to assess the reversibility of any observed effects.