Toxicological drug study

Toxicology. The study of the harmful effects of drugs on physiology. 

Hazelette, J., Thompson, T., Mertz, B., Vuolo-Schuessler, L., Gree, J., Tripp, S., Robertson, P. and Triana, V (1987). Rising dose tolerance (RDT) study A novel scenario for obtaining preclinical toxicology/drug metabolism data. Toxicologist 7, Abstract 846. 

Successful completion of the above experiments will characterize methods for use in evaluating a lead candidate in animal models. If a candidate is selected for further development, the method will need to be validated (3,4) for each matrix and for each species before being used to support definitive toxicology, drug metabolism, and pharmacokinetic studies. 

The adverse reaction potential of an investigational new drug, to some extent, may be indicated by its molecular structural similarities to other drugs of known actions and by pharmacologic and toxicologic preclinical studies in appropriate species of laboratory animals. The full adverse reaction profile of a drug, how-... 

Note Depending on the drug program other toxicological/pharmacological studies may be conducted in addition to the studies listed above. 

Hoeng, J., Talikka, M., Martin, R, et al. 2014. Case study the role of mechanistic network models in systems toxicology. Drug Discov. Today 19(2) 183-192. 

Polarographic determinations have been mainly used in clinical chemistry, toxicology, and studies on pharmacokinetics and therapeutic drug monitoring. 

MBP is an excellent ASD technique, particularly during early phase of drug development and for toxicology-enabling studies. Because of the excellent recovery rate and flexibility in scale, even milligram quantity drug can be processed to enable animal pharmacokinetic (PK) studies. This makes MBP technique particularly attractive for early drug assessment studies. 

Considerable studies are required to establish the toxicological profile of the drug substance. These must assess its direct toxic effects, together with its potential as a reproductive toxin, mutagen, or carcinogen. 

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