Biomaterial Database

Basic requirements for the toxicity testing of antimicrobial agents. 1990

R Bass, and T Lehnert

Institute for Drugs, Federal Health Office, Berlin, FRG.

The regulations in different countries on the toxicological testing of antimicrobial agents are similar and harmonized on an international basis. Existing requirements cover both the standard investigations performed with any other new class of therapeutic drug and investigations necessary due to the specific features of anti-infective agents. Such features are the therapeutic target (the microorganisms), the need to provide adequate treatment of patients even during clinical trials, and the potential of the drug to induce certain adverse reactions. The combination of toxicity tests used will be determined by the drug, its class and current knowledge.

UI	MeSH Term	Description	Entries
D007564	Japan	A country in eastern Asia, island chain between the North Pacific Ocean and the Sea of Japan, east of the Korean Peninsula. The capital is Tokyo.	Bonin Islands
D007883	Legislation, Medical	Laws and regulations, pertaining to the field of medicine, proposed for enactment or enacted by a legislative body.	Medical Legislation
D010600	Pharmacology	The study of the origin, nature, properties, and actions of drugs and their effects on living organisms.	Pharmacologies
D004341	Drug Evaluation	Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.	Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D005060	Europe	The continent north of AFRICA, west of ASIA and east of the ATLANTIC OCEAN.	Northern Europe,Southern Europe,Western Europe
D006291	Health Policy	Decisions, usually developed by government policymakers, for determining present and future objectives pertaining to the health care system.	Health Care Policies,Health Policies,Healthcare Policy,National Health Policy,Care Policies, Health,Health Care Policy,Health Policy, National,Healthcare Policies,National Health Policies,Policies, Health,Policies, Health Care,Policies, Healthcare,Policy, Health,Policy, Health Care,Policy, Healthcare
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000818	Animals	Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA.	Animal,Metazoa,Animalia
D000890	Anti-Infective Agents	Substances that prevent infectious agents or organisms from spreading or kill infectious agents in order to prevent the spread of infection.	Anti-Infective Agent,Anti-Microbial Agent,Antimicrobial Agent,Microbicide,Microbicides,Anti-Microbial Agents,Antiinfective Agents,Antimicrobial Agents,Agent, Anti-Infective,Agent, Anti-Microbial,Agent, Antimicrobial,Agents, Anti-Infective,Agents, Anti-Microbial,Agents, Antiinfective,Agents, Antimicrobial,Anti Infective Agent,Anti Infective Agents,Anti Microbial Agent,Anti Microbial Agents
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.