Insights into toxicology, safety pharmacology, and drug dependence testing: The performance and predictive values of nonclinical tests.

Autor: Suarez-Torres JD; Department of Toxicology, Department of Pharmacy, Universidad Nacional de Colombia, Bogotá, Colombia; Institute of Pharmaceutical Research, School of Pharmacy, Universidad Central de Venezuela, Caracas, Venezuela. Electronic address: jdsuarezto@outlook.com., Ciangherotti CE; Institute of Pharmaceutical Research, School of Pharmacy, Universidad Central de Venezuela, Caracas, Venezuela; Laboratory of Neuropeptides, School of Pharmacy, Universidad Central de Venezuela, Caracas, Venezuela., Jimenez-Orozco FA; Department of Pharmacology, Faculty of Medicine, Universidad Nacional Autónoma de México, Ciudad de México, Mexico.
Jazyk: angličtina
Zdroj: Journal of pharmacological and toxicological methods [J Pharmacol Toxicol Methods] 2020 May - Jun; Vol. 103, pp. 106684. Date of Electronic Publication: 2020 Mar 12.
DOI: 10.1016/j.vascn.2020.106684
Abstrakt: The pre-marketing testing of drugs and chemicals is now a paradigm of contribution to the safeguard of public health. As pointed out by the ICH concept paper E14/S7B, there is a need for science-based frameworks that allow a better design, conduction, and interpretation of nonclinical and toxicity tests, particularly, in order for those assays to influence nonclinical and clinical evaluations and decisions better. Critical issues related to the performance and predictive values of nonclinical testing were highlighted and discussed in this article, specifically, to help pharmacologists, toxicologists, and regulators in the evaluation of the reliability of such tests, and basing the prospective decisions on the true predictivity of selected screening tests. This review addressed two common mistakes in drug and chemical testing, namely, (a) the assumption of either sensitivity or specificity as automatically "predictive," and (b) the reporting of the predictive values disregarding a truly representative prevalence. This review also discussed a statistical basis to apply for (industry standpoint) or grant (regulatory standpoint) authorization for the waiving of selected nonclinical tests. Furthermore, this review can be guiding for those who are entering into the field of drug and chemical testing. Through application, investigation, and enhancement of the conceptual framework discussed in this review, nonclinical testing is expected to provide a higher contribution to drug and chemical development, regulatory science, and public health.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2020 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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