Evaluation of drug safety by toxicological test procedures as provided by regulatory laws: An overview

Abstract

Regulatory laws designed to ascertain the safety and to accept the introduction into clinics of new drugs are relatively recent [1-6] . They have been very strictly drawn by national and international regulatory authorities with rigid protocols that are routinely and strictly applied in the toxicology laboratories of pharmaceutical industry. Toxicological testing procedures, unlike regulatory laws, should be flexible rather than rigid so as to permit a full range of toxicological exploration . The regulations, too, should allow and/or encourage the application of nonstandard tests based on chemical or pharmacological knowledge or on the feedback from preliminary experiments on animals or human beings . Safety assessment in humans in the use of a new drug is, therefore, a complex and multiple process hard to quantify and requiring the collection of the results of toxicity tests on animals, their interpretation in the context of pharmacodynamic and biochemical data and their statistical analysis . Safety assessment is a scientific undertaking for obtaining the basis on which to assess the benefit-risk ratio of drugs. Gaps in our knowledge of toxicological mechanisms still prejudice results .