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Regulatory aspects in the perinatal toxicology
Pharmacological Research, Vol. 22, Supplement Z, 1990
71
REGULATORY ASPECTS IN THE PERINATAL TOXICOLOGY BUSSI Rita Istituto di Ricerche Biomediche "A. Marxer", RBM S.p.A. P.O. Box 226 - 10015 IVREA (Torino), Italy Perinatal toxicology is concerned with postnatal behavioral effects resulting from prenatal exposure to a suspect agent. Recently there has been a growing concern and an increase in research efforts in this area. Adverse effects on the survival, physical and functional development of the newborns can arise from an exposure to exogenous substances during the classic period of organogenesis and after this period, e.g. during the fetogenesis and during lactation. Exposure to an agent in these last periods (peri- and postnatal period) may also impair reproductive performance. In these periods the effects may result for the presence of the exogenous agents in the mother's milk, or from direct exposure of the young to the agent. In developed countries (USA, Japan, Europe) official Regulatory Agencies currently set specific study protocols for the testing of drugs before these are permitted to enter or to remain on the market. Since some differences are present in these study protocols, Regulatory Agencies should stimulate research and try to harmonize the different guidelines in order to protect the public from risk in a meaningful and most effective way.
1043--6618/90/22110071-0 I/$03.00/0
© 1990 The Italian Pharmacological Society
71
REGULATORY ASPECTS IN THE PERINATAL TOXICOLOGY BUSSI Rita Istituto di Ricerche Biomediche "A. Marxer", RBM S.p.A. P.O. Box 226 - 10015 IVREA (Torino), Italy Perinatal toxicology is concerned with postnatal behavioral effects resulting from prenatal exposure to a suspect agent. Recently there has been a growing concern and an increase in research efforts in this area. Adverse effects on the survival, physical and functional development of the newborns can arise from an exposure to exogenous substances during the classic period of organogenesis and after this period, e.g. during the fetogenesis and during lactation. Exposure to an agent in these last periods (peri- and postnatal period) may also impair reproductive performance. In these periods the effects may result for the presence of the exogenous agents in the mother's milk, or from direct exposure of the young to the agent. In developed countries (USA, Japan, Europe) official Regulatory Agencies currently set specific study protocols for the testing of drugs before these are permitted to enter or to remain on the market. Since some differences are present in these study protocols, Regulatory Agencies should stimulate research and try to harmonize the different guidelines in order to protect the public from risk in a meaningful and most effective way.
1043--6618/90/22110071-0 I/$03.00/0
© 1990 The Italian Pharmacological Society