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Postnatal testing--a regulator's viewpoint.

¹Medicines Division, Department of Health and Social Security, London, United Kingdom.

Regulatory Toxicology and Pharmacology : RTP

|September 1, 1988

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UK regulations require animal testing for postnatal drug effects, focusing on offspring development. Industry interpretation of these 1975 guidelines has varied widely over 12 years.

Area of Science:

Pharmacology and Toxicology
Developmental Toxicology
Regulatory Science

Background:

UK regulations mandate postnatal effects testing for human medicines since 1975.
Guidelines suggest assessing offspring's auditory, visual, and behavioral functions in fertility and perinatal studies.
Pharmaceutical industry interpretation of these requirements has been broad over the past 12 years.

Purpose of the Study:

To discuss the types of postnatal tests conducted on new chemical entities.
To analyze these tests, especially for drugs targeting the central nervous system.
To evaluate the role of postnatal test results in new drug safety assessments.

Main Methods:

Review of postnatal study submissions by the pharmaceutical industry.

Related Experiment Videos

Categorization of tests from simple physical development indices to complex behavioral assessments.

Focus on studies for new chemical entities, particularly those with central nervous system activity.

Main Results:

Significant variation exists in the scope and complexity of postnatal studies performed.
A wide range of tests, from basic development to advanced behavioral evaluations, are utilized.
Postnatal test results are crucial for evaluating the safety of new medicinal products.

Conclusions:

The interpretation and application of postnatal testing requirements have evolved significantly.
Postnatal assessments provide critical data for the comprehensive safety evaluation of new drugs.
Further discussion is needed on the role and standardization of these tests in drug development.