Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2005, 149(2):209-212 | DOI: 10.5507/bp.2005.027

Developmental toxicology - An integral part of safety evaluation of new drugs

Eduard Ujházy^a, Mojmír Mach^a, Michal Dubovický^a, Jana Navarová^a, Ingrid Brucknerová^b

^a Laboratory of Teratology, Institute of Experimental Pharmacology, Slovak Academy of Sciences, Bratislava, Slovakia

^b 1st Department of Paediatrics, School of Medicine, Comenius University, Bratislava, Slovakia

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.

Keywords: Developmental toxicology, Teratology, Screening tests, Biomodels

Received: June 10, 2005; Accepted: September 25, 2005; Published: December 1, 2005  Show citation