Biomaterial Database

Overview of safety pharmacology. 2006

Roger D Porsolt

Porsolt & Partners Pharmacology, Boulogne-Billancourt, France.

Safety pharmacology assesses the potential risks of novel pharmaceuticals for human use. ICH S7A guidelines recommend a core battery of studies on three vital systems: central nervous system (CNS), cardiovascular (CV) and respiratory. Primary CNS studies look for effects on general behavior, locomotion, neuromuscular coordination, the convulsive threshold, and vigilance. The primary CV test battery evaluates proarrhythmic risk using in vitro approaches (hERG channel and Purkinje fiber assays) and in vivo measurements in conscious animals via telemetry. Comprehensive cardiac risk assessment also includes full hemodynamic evaluation, most suitably conducted in the anesthetized large animal. Basic respiratory function can be approached via whole-body plethysmography in conscious animals where sensitivity to respiratory-depressant effects can be enhanced by exposure to increased CO(2). Other aspects of safety pharmacology studies discussed are the timing of studies, ethical and animal welfare issues, and statistical evaluation.

UI	MeSH Term	Description	Entries
D007753	Laboratories	Facilities equipped to carry out investigative procedures.	Laboratory
D011364	Professional Practice	The use of one's knowledge in a particular profession. It includes, in the case of the field of biomedicine, professional activities related to health care and the actual performance of the duties related to the provision of health care.	Practice, Professional,Practices, Professional,Professional Practices
D012140	Respiratory Tract Diseases	Diseases involving the RESPIRATORY SYSTEM.	Respiratory Diseases,Respiratory System Diseases,Disease, Respiratory System,Disease, Respiratory Tract,Respiratory System Disease,Respiratory Tract Disease
D002318	Cardiovascular Diseases	Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.	Adverse Cardiac Event,Cardiac Events,Major Adverse Cardiac Events,Adverse Cardiac Events,Cardiac Event,Cardiac Event, Adverse,Cardiac Events, Adverse,Cardiovascular Disease,Disease, Cardiovascular,Event, Cardiac
D002493	Central Nervous System Diseases	Diseases of any component of the brain (including the cerebral hemispheres, diencephalon, brain stem, and cerebellum) or the spinal cord.	CNS Disease,Central Nervous System Disease,Central Nervous System Disorder,CNS Diseases,Central Nervous System Disorders
D004353	Drug Evaluation, Preclinical	Preclinical testing of drugs in experimental animals or in vitro for their biological and toxic effects and potential clinical applications.	Drug Screening,Evaluation Studies, Drug, Pre-Clinical,Drug Evaluation Studies, Preclinical,Drug Evaluations, Preclinical,Evaluation Studies, Drug, Preclinical,Evaluation, Preclinical Drug,Evaluations, Preclinical Drug,Medicinal Plants Testing, Preclinical,Preclinical Drug Evaluation,Preclinical Drug Evaluations,Drug Screenings,Screening, Drug,Screenings, Drug
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000827	Animal Welfare	The protection of animals in laboratories or other specific environments by promoting their health through better nutrition, housing, and care.	Animal Cruelty,Cruelty, Animal,Welfare, Animal
D001675	Bioethics	A branch of applied ethics that studies the value implications of practices and developments in life sciences, medicine, and health care.	Biomedical Ethics,Health Care Ethics,Ethics, Biomedical,Ethics, Health Care
D012449	Safety	Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.	Safeties