ABSTRACT

This chapter provides the primary consideration to the development of pharmacological agents as therapeutic drugs, but a similar approach should be adopted for potential chemotherapeutic agents such as antiviral, anticancer or anti-parasitic drugs. The primary safety evaluation of the new chemical entity (NCE) will be reported in the toxicology section of the application. However, a general pharmacological profile of the NCE is also required, with special attention to any effects additional to the primary pharmacological action. Almost without exception, the pharmaceutical industry assesses the overall behavioural effects of the NCE in mice. The majority of pharmaceutical companies evaluate the cardiovascular profile of the NCE in some detail, including changes in heart rate and systemic arterial blood pressure, in both anaesthetised and conscious laboratory animals. Many companies monitor the effect of the NCE on diuresis in salt-loaded rats as part of the routine pharmacological profile.