Developmental toxicology - an integral part of safety evaluation of new drugs. 2005

Eduard Ujházy, and Mojmír Mach, and Michal Dubovický, and Jana Navarová, and Ingrid Brucknerová
Laboratory of Teratology, Institute of Experimental Pharmacology, Slovak Academy of Sciences, Bratislava, Slovakia. exfaujha@savba.sk

The thalidomide tragedy stimulated an intense research in the etiology, prevention and treatment of congenital malformations. The Government requires that drugs and food additives be evaluated pre-clinically for toxicity, including developmental toxicity, before being marketed. The number of compounds which must be tested has increased dramatically with the continuous development of therapeutic, cosmetic and food additive chemicals. Such tests include: in vitro studies which can serve as efficient pre-screens to rank chemicals for further batteries of in vivo tests on pregnant animals. However, the safety of any drug would be determined only by a post-marketing epidemiological survey. Taking into account the altered susceptibility to different drugs in a pregnant individual, it could be said that administration of any drug during the first trimester is an experiment in human teratology.

UI MeSH Term Description Entries
D011247 Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. Gestation,Pregnancies
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
D005260 Female Females
D005313 Fetal Death Death of the developing young in utero. BIRTH of a dead FETUS is STILLBIRTH. Fetal Mummification,Fetal Demise,Death, Fetal,Deaths, Fetal,Demise, Fetal,Fetal Deaths,Mummification, Fetal
D005317 Fetal Growth Retardation Failure of a FETUS to attain expected GROWTH. Growth Retardation, Intrauterine,Intrauterine Growth Retardation,Fetal Growth Restriction,Intrauterine Growth Restriction
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000014 Abnormalities, Drug-Induced Congenital abnormalities caused by medicinal substances or drugs of abuse given to or taken by the mother, or to which she is inadvertently exposed during the manufacture of such substances. The concept excludes abnormalities resulting from exposure to non-medicinal chemicals in the environment. Drug-Induced Abnormalities,Abnormalities, Drug Induced,Abnormality, Drug-Induced,Drug Induced Abnormalities,Drug-Induced Abnormality
D013723 Teratogens An agent that causes the production of physical defects in the developing embryo. Embryotoxins,Fetotoxins,Teratogen
D018600 Teratology A branch of embryology for the study of congenital malformations and developmental abnormalities. Teratologies

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