Cardiovascular safety pharmacology core battery

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). 

Safety pharmacology studies have been subdivided into "core battery," "follow-up," and "supplemental" studies.25 The "core battery" studies are aimed to investigate the effects of NCEs on the cardiovascular, respiratory, and central nervous systems that are considered as vital organ systems based on the fact that acute failure of these systems would pose an immediate hazard to human life. In some instances, based on scientific rational, the "core battery" may or may not be supplemented.25 Additionally, ADRs may be either (1) suspected based on the pharmacological class, or the chemical class, or (2) identified... 

Issues of cardiovascular safety have brought safety pharmacology to the forefront, especially with issues like prolongation of the QTc interval. In the United States, IND s must routinely include the core battery of cardiovascular, CNS, and pulmonary function studies. The reader is referred to Chapter 13 for a thorough discussion of this important topic. 

S7A differentiates between 3 types of studies core battery, follow-up and supplemental studies. The core battery of tests/S7A consistes of an investigation of the effects of a test substance on vital functions central nervous system cardiovascular system respiratory system other systems as appropriate. The exclusion of a system or function should be justified. Safety Pharmacology studies carried out as necessary as ... 

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