clinical research database
Session 28
Safety Pharmacology Studies for Human Pharmaceuticals
This guidance was developed to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources.
This guidance provides a definition, general principles, and recommendations for safety pharmacology studies.
Pharmacology studies have been performed worldwide for many years as part of the nonclinical evaluation of pharmaceuticals for human use. There have been, however, no internationally accepted definitions, objectives or recommendations on the design and conduct of safety pharmacology studies. (Note 1)
The term safety pharmacology studies first appeared in ICH M3 Timing of Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals and S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals as studies that should be conducted to support use of therapeutics in humans (1, 2). Details of the safety pharmacology studies, including their definition and objectives, were left for future discussion.
A. Scope of the Guidance (1.3)
This guidance generally applies to new chemical entities and biotechnology-derived products for human use. This guidance can be applied to marketed pharmaceuticals when appropriate (e.g., when adverse clinical events, a new patient population, or a new route of administration raises concerns not previously addressed).
B. General Principle (1.4)
It is important to adopt a rational approach when selecting and conducting safety pharmacology studies. The specific studies that should be conducted and their design will vary based on the individual properties and intended uses of the pharmaceuticals. Scientifically valid methods should be used, and when there are internationally recognized methods that are applicable to pharmaceuticals, these methods are preferable. Moreover, the
Safety Pharmacology Studies for Human Pharmaceuticals
This guidance was developed to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources.
This guidance provides a definition, general principles, and recommendations for safety pharmacology studies.
Pharmacology studies have been performed worldwide for many years as part of the nonclinical evaluation of pharmaceuticals for human use. There have been, however, no internationally accepted definitions, objectives or recommendations on the design and conduct of safety pharmacology studies. (Note 1)
The term safety pharmacology studies first appeared in ICH M3 Timing of Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals and S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals as studies that should be conducted to support use of therapeutics in humans (1, 2). Details of the safety pharmacology studies, including their definition and objectives, were left for future discussion.
A. Scope of the Guidance (1.3)
This guidance generally applies to new chemical entities and biotechnology-derived products for human use. This guidance can be applied to marketed pharmaceuticals when appropriate (e.g., when adverse clinical events, a new patient population, or a new route of administration raises concerns not previously addressed).
B. General Principle (1.4)
It is important to adopt a rational approach when selecting and conducting safety pharmacology studies. The specific studies that should be conducted and their design will vary based on the individual properties and intended uses of the pharmaceuticals. Scientifically valid methods should be used, and when there are internationally recognized methods that are applicable to pharmaceuticals, these methods are preferable. Moreover, the
References: (4) 1. ICH M3 Timing of Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (FDA, 1997). 2. ICH S6 Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals (FDA, 1997). 3. Mattsson, J. L., P. J. Spencer, and R. R. Albee, "A Performance Standard for Clinical and Functional Observational Battery Examinations of Rats," Journal of the American College of Toxicology, 15: 239 (1996). 4. Irwin, S., "Comprehensive Observational Assessment: 1a. A Systematic, Quantitative Procedure for Assessing the Behavioural and Physiologic State of the Mouse," Psychopharmacologia (Berlin), 13:222-257 (1968). 5. Haggerty, G. C., "Strategies for and Experience with Neurotoxicity Testing of New Pharmaceuticals," Journal of the American College of Toxicology, 10:677-687 (1991). 6. Murphy, D. J., "Safety Pharmacology of the Respiratory System: Techniques and Study Design," Drug Development Research, 32: 237-246 (1994). Please list, in general terms, the principles of safety pharmacology studies in humans.