Safety studies toxicology

At that time, a full review of companies and institutions conducting non-clinical safety studies (toxicology) was undertaken by the FDA and although, in general, the industry was found to be credible, one company (Industrial Biotest) was found to be generating extremely poor-quality data, in many instances, in a fraudulent manner. This, therefore, caused the FDA to put together and implement the GLPs.[" ""l... 

Use data from preclinical pharmacology toxicology ( safety ) studies to support the safety of clinical trials. 

Barrow P (2000) Reproductive and developmental toxicology safety studies. In Krinke G (ed) The laboratory rat. Academic, London, pp 199-225... 

The conduct of toxicology studies in laboratory animals has been driven by experience, historical precedence, and governmental requirements, and the results of these studies usually, and reasonably, have led to restrictions on the use, or method of use, of the chemicals concerned [1], The primary objective of pharmaceutical preclinical safety evaluation is to provide information essential for the initiation of clinical trials. Scientific rationale and controlled reproducible data are used to show that the initial human risk is so low as to be ethically and practically acceptable in relation to the medical value of the information to be obtained from humans. Preclinical safety studies performed throughout the course of product development facilitate and may guide work... 

Safety concerns may arise from the presence of impurities or contaminants. It is preferable to rely on purification processes to remove impurities and contaminants rather than to establish a preclinical testing program for their qualification. In all cases, the product should be sufficiently characterized to allow an appropriate design of preclinical safety studies. In general, the product that is used in the definitive pharmacology and toxicology studies should be comparable to the product proposed for the initial clinical studies. (ICH S6)... 

Fertility and early embryonic development rats Developmental rats, rabbits Prenatal and postnatal development rats Genetic toxicology in vitro bacterial and CFIO cell assays, mouse micronucleus assay Carcinogenicity proliferation in vitro and in vivo Tissue cross-reactivity human tissues Other safety studies in a variety of species Single dose none... 

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