Regulatory toxicology studies

In China, research on reproductive safety assessment is primarily conducted in state laboratories. In addition, there are contract research laboratories which are accredited to conduct regulatory toxicology studies. India in particular has well established GLP testing facilities. 

This chapter describes the regulatory toxicology studies required for the reproductive safety evaluation of food additives, with particular attention to the detection of teratogenicity. 

Ellegaard L et al, under the auspices of the Steering Group of the RETHINK Project (2010) Wellare of the minipig with special reference to use in regulatory toxicology studies. J Pharmacol Toxicol Methods 62 167-183... 

Regulatory toxicology studies performed before drug is administered to humans for the first time in FTIH studies. 

Regulatory toxicology studies performed in parallel with clinical trials. 

Other regulatory toxicology studies are typically conducted in parallel with clinical trials. These include ... 

Any detailed examination on intrauterine development, sex differentiation, and pubertal development is beyond the scope of this discussion. Highly specialised methods need to be applied, and there is usually no indication for such effects from the early regulatory toxicology studies (28 days in rats and dogs). The special aspects of toxicological findings with xenobiotics have been reviewed for the female reproductive tract... 

Fig. 3.1 Drug discovery sources in context. Different types of chemicai compounds (top left) are tested against bioassays that are relevant to therapeutic targets, which are derived from several possible sources of information (right).The initial lead compounds discovered by the screening process are optimised by analogue synthesis and tested for appropriate pharmacokinetic properties.The candidate compounds then enter the development process involving regulatory toxicology studies and clinical trials.

Some molecules, such as amino acids, which are also ionized, are rarely measured in regulatory toxicology studies however, the amino acids are some of the major metabolites measured by nuclear magnetic resonance spectroscopy for toxicological purposes (Lindon, Holmes, and Nicholson 2004). 

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