Regulatory agencies focus

Regulatory agencies also attempt to develop more realistic estimates, but this is difficult, and a scientific consensus on just what exposure pattern should be presumed desirable for risk assessment is not available, except for a few circumstances (food additives, human drugs, and a few others). Much attention is now focused on methods to develop information on the full distribution of exposures in a population, but this can be technically difficult to achieve. 

In contrast, the majority of the newer regulatory agencies have been mandated to resolve social or economic problems wherever they are perceived to arise. In some cases, the mandate has resulted in regulations to which all (or a very wide range of) industries are immediately subject. In other cases, agencies have focused on a few industries at a time, but with the clear prospect that all industries are potentially subject to future action. 

Various regulatory agencies around the world are working to increase the number of clinical trials involving children. The FDA s Office of Pediatric Therapeutics focuses on both clinical and ethical aspects of clinical research in pediatric populations and works to increase the scientific understanding of the medical needs of children. 

In previous chapters, discussion has focused on superiority trials. These trials are conducted to demonstrate to the satisfaction of regulatory agencies that the investigational drug is superior in efficacy to a placebo, or possibly superior in efficacy to an active comparator. In addition, this chapter also introduces other study designs that are very informative and, in some cases, necessary. 

Overall the ICH S7A guideline is successfully implemented in the pharmaceutical world. The core battery is in general performed prior to First in Man . The guideline increases the visibility of safety pharmacology within companies and increases focus by regulatory agencies. 

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