Types of Toxicological Studies

This chapter provides a survey of US marketed biopharmaceuticals approved over the past 20 years. It is a simply a profile of the species and types of toxicology studies done for each drug for marketing approval. For a complete list of all preclinical studies for a biopharmaceutical, the reader is directed to the Web sites of the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). 

A number of preclinical toxicology studies need to be completed and documented in a regulatory agency submission before initiating human clinical trials. The number and types of toxicology studies depend on... 

As described elsewhere in this Volume, the aim of the toxicological (and microbiological) studies is to allow the identification of a no-observed effect level (NOEL) and the calculation of an acceptable daily intake (ADI) (11). The safety file specifies the types of toxicological study that are usually required to allow the construction of the toxicological profile of a veterinary drug active ingredient and to identify the NEL. These include the following ... 

There must be considerable overlap here between the basic pharmacodynamic and pharmacological experimentation, which has shown why the intended product may be of therapeutic value and the mechanisms of that desired activity, and the range of investigations that it is necessary and worthwhile to apply in the types of preclinical studies usually labeled as toxicology, here including pharmacokinetics. 

Many of the fields of study and types of toxicology are described below. These efforts are very broad and entail the use of many disciplines. 

In conclusion, proteomics has demonstrated to be an extremely powerful tool in toxicology. It is believed that proteomics will become a must have technology with the development of new types of MS instruments and improvements in technical specifications. Performance of toxicological studies on a systems biology level by integrating proteomics data with other omics data will likely provide the most comprehensive and informative information to better understand the mechanisms of toxicity and disease. 

Species Strain and genders Type of toxicological/pharmacological studies... 

Before a new type of food surfactant is permitted for use by the health authorities it has to be tested in a number of toxicological studies including short-term and long-term feeding trials on several species together with studies on metabolism. (WHO, 1974). 

UV absorbers for sunscreens should provide an efficient absorption of UV radiation (UVB and/or UVA), and it must be possible to incorporate them into various types of formulation in sufficient amounts. The safety of these substances has to be shown in an extensive program of toxicological studies, such as acute oral toxicity, chronic toxicity, dermal toxicity, embryo-fetal toxicity, photo-irritation, percutaneous absorption, carcinogenicity, photocarcinogenicity, pharmacokinetics and metabolism. 

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