Postnatal testing--a regulator's viewpoint.
In the UK the requirement to test animals for postnatal effects currently only applies to human medicines. The requirement was introduced in 1975 with general guidelines. They state that in the fertility and in some cases in the perinatal studies, in addition to testing the reproductive capacity of the offspring, the late effects of the drug on the progeny, in terms of auditory, visual, and behavioural function, should be assessed. Over the last 12 years this requirement has been interpreted very widely by the pharmaceutical industry. The postnatal studies submitted vary from the simple indices of physical development undertaken on some compounds to a wide variety of more complex behavioural tests undertaken on others. The types of postnatal tests presented on new chemical entity medicinal products are discussed, particularly those undertaken on drugs with therapeutic actions on the central nervous system. The results of the postnatal tests and their role in the assessment of the safety of new drugs are discussed.
Grieve
S J
SJ
Medicines Division, Department of Health and Social Security, London, United Kingdom.
D000818:Animals; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D012107:Research Design; D012449:Safety; D006113:United Kingdom