Before revision: The animal study endpoint is clearly related to the desired benefit in humans; and Data or information on the pharmacokinetics and pharmaco–dynamics of the product or other relevant data or information in animals or humans is sufficiently well understood to allow selection of an effective dose in humans, and it is, therefore, reasonable to expect the effectiveness of the product in animals to be a reliable indicator of its effectiveness in humans.
After revision: The animal study endpoint is clearly related to the desired benefit in humans; and Data or information on the pharmacokinetics and pharmacodynamics of the product or other relevant data or information in animals or humans is sufficiently well understood to allow selection of an effective dose in humans, and it is, therefore, reasonable to expect the effectiveness of the product in animals to be a reliable indicator of its effectiveness in humans.