Safety Pharmacology refers to the assessment of adverse effects of chemicals and drugs on functional and physiological systems including cardiovascular, respiratory, central and peripheral nervous system, renal and gastrointestinal functions. The evaluation of functional or physiological toxicities plays a key role in safety assessment process, and should be viewed as complementary to traditional assessments of toxicity based upon morphological or biochemical lesions.  Safety pharmacology is not a new topic, but one with renewed interest in the pharmaceutical industry and the regulatory bodies governing the drug approval process.

The authors of this Practical Guide have assembled information to assist scientists in 1) understanding the recent regulatory status and expectations for safety pharmacology testing, and 2) the conduct of safety pharmacology studies. As evidenced by their extensive experience, the authors share a deep commitment to the conduct of safety pharmacology studies and are leaders in the field of drug safety assessment. The emphasis of the guide is to provide practical information and approaches to the assessment  of cardiovascular electrophysiological, central and peripheral nervous system and renal and gastrointestinal functions.

An emphasis on protocol design and data interpretation will give the reader an opportunity to experience safety pharmacology in a virtual reality mode.  While the contributors to this guide highlight specific approaches based upon their experience for the respective safety pharmacology assessments, it is important that the reader leave with a clear perspective that encourages creativity and flexibility in preparing a safety pharmacology package on new drug candidates. "There is no one approach or single safety pharmacology package that needs to be done!" Thus, the guide includes an illustration of a variety of safety pharmacology packages that could be considered to fulfill ethical and regulatory requirements.

• Co-Authors:
  • Alan S. Bass
  • Mary Jeanne Kallman
  • Lewis B. Klinter
  • David K. Johnson
  • Dennis J. Murphy
  • Leslie Patmore
  • Patricia D. Williams