Scientific Publications by FDA Staff

Drug Dev Res 1994 Aug;32(4):233-6

Regulatory considerations on the role of general pharmacology studies in the development of therapeutic agents

Proakis AG

In contrast to the well-defined regulatory requirements for the conduct of animal toxicology studies, FDA regulations and guidelines for nonclinical pharmacodynamic studies are relatively general and do not require that any specific studies be conducted. General pharmacology studies are conducted to identify actions of a new agent in addition to those associated with the primary therapeutic utility. General pharmacology studies aimed at determining drug effects on cardiovascular, central nervous system, gastrointestinal, respiratory and pulmonary, renal, endocrine and metabolism, autonomic nervous system, and drug-receptor functions were among the types of general pharmacology studies included in a sample of recent investigational new drug application (IND) and new drug application (NDA) submissions. Assessment of drug effects on cardiovascular, autonomic nervous system, and drug-receptor interactions were given the greatest individual importance in identifying drug effects relevant to the assessment of a product's safety at the initial IND stage. At the NDA stage, general pharmacology studies find their greatest value in predicting drug-drug interactions, defining mechanisms of action, characterizing the pharmacological correlates of drug-overdose, identifying dose-limiting effects for the chronic toxicity studies, and associating animal toxicity findings with known pharmacotoxic effects. General pharmacology studies provide valuable information to complement animal toxicity studies for evaluating a drug's potential risk to humans.