Status of safety pharmacology in the pharmaceutical industry—1995

Abstract

AbstractSafety pharmacology contributes to the pharmacological characterization, risk assessment, and registration of new drugs; however, safety pharmacology strategies and study designs for new drugs vary widely across the pharmaceutical industry. We surveyed 26 pharmaceutical companies for how and why they conduct safety pharmacology studies. All conduct/contract safety pharmacology studies; 19 have safety pharmacology units, seven do not; ten locate responsibility for safety pharmacology in development, 16 in discovery (or research). Total staff range from two to 16 full‐time equivalents (fte)/unit. Most companies conduct evaluations of cardiovascular and CNS functions, less evaluate respiratory, gastrointestinal and renal functions; a few conduct a ligand‐binding/activity panel as part of their pharmacological profiling. Resources to complete a company's standard safety pharmacology program are ∼1–4 fte/compound. One‐third of companies use a maximum tolerated dose (MTD) for safety pharmacology studies, two‐thirds use multiples of pharmacological or therapeutic doses. Approximately half conduct safety pharmacology studies to Good Laboratory Practices (GLPs) and use the 1992 Japanese guidelines only as a guide or outline. Company clinicians are most often cited as the “primary customer” for whom Safety Pharmacology studies are done, followed by research and development scientists, and then regulatory authorities. The results suggest that most companies conduct safety pharmacology for its contribution to risk assessment and critical care management. © 1995 Wiley‐Liss, Inc.