Safety pharmacology core battery

The safety pharmacology "core battery" studies should be available prior to first administration in humans. Furthermore, "follow-up" and "supplemental" studies should also be available prior to first administration in humans if there are specific cause for concerns. During clinical development, additional studies may be warranted to clarify observed or suspected adverse effects in animals or humans. Finally, prior to product approval, effects on organ systems that are defined as part of "follow-up" and "supplemental" studies should be assessed, unless not warranted. Available information from toxicology or clinical studies can support this assessment and replace the need for stand-alone safety pharmacology studies. 

The purpose of the safety pharmacology core battery is to investigate the effects of the test substance on vital functions. In this regard, the cardiovascular, respiratory and central nervous systems are usually considered the vital organ systems that should be studied in the core battery. In some instances, based on scientific rationale, the core battery may need to be supplemented (see also section 2.8) or may not need to be implemented (see also section 2.9). 

Adverse effects may be suspected based on the pharmacological properties or chemical class safety pharmacology core battery, clinical trials, phar-macovigilance, or from literature reports. When such... 

The core battery of tests as well as the supplementary safety pharmacology studies can be conducted at the very beginning of in vivo screening and, at the latest, before first studies in man. The safety pharmacology core battery of tests as well as followup and supplemental studies should be conducted in compliance with good laboratory practice (GLP). Any study or study component not conducted in compliance with GLP should be adequately justified, and the potential impact on evaluation of the safety pharmacology endpoints should be explained. 

Safety pharmacology Core battery Dedicated Integrated into toxicity studies... 

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