Journal ArticleDOI
Predictive value of animal studies in toxicology.
Reads0
Chats0
TLDR
Toxicology has reached a satisfactory level of performance in identifying toxicity in animals, and experimental techniques are now available to characterize the toxicological potential of chemical substances in great detail.About:
This article is published in Regulatory Toxicology and Pharmacology.The article was published on 1991-10-01. It has received 66 citations till now.read more
Citations
More filters
Journal ArticleDOI
Concordance of the toxicity of pharmaceuticals in humans and in animals.
Harry Olson,Graham Betton,Denise Robinson,Karluss Thomas,A.M. Monro,Gerald Kolaja,Patrick D. Lilly,James E. Sanders,Glenn Sipes,William Bracken,Michael A. Dorato,Koen Van Deun,Peter Smith,Bruce Berger,Allen H. Heller +14 more
TL;DR: The survey results support the value of in vivo toxicology studies to predict for many significant HTs associated with pharmaceuticals and have helped to identify HT categories that may benefit from improved methods.
Journal ArticleDOI
Preclinical safety evaluation of biotechnology-derived pharmaceuticals
TL;DR: To what extent animal toxicity studies can lead to safer drugs in humans?
Journal ArticleDOI
Polypharmacology - foe or friend?
TL;DR: This perspective aims to provide a balanced view on polypharmacology, which can compromise the safety of drugs, but can also confer superior efficacy.
Journal ArticleDOI
The dawning of a new age of toxicology.
TL;DR: Toxicology is changing from being a predominantly observational craft and regulatory support discipline back to a natural science with all its dimensions, which requires a radical paradigm shift in the approach to safety assessments, and turns the traditional procedures upside down.
Journal ArticleDOI
The carcinogenesis bioassay in perspective: application in identifying human cancer hazards.
TL;DR: It is predicted that less than 5-10% of the 75,000 chemicals in commercial use might be reasonably anticipated to be carcinogenic to humans.
References
More filters
Journal ArticleDOI
Drug Safety Tests and Subsequent Clinical Experience
TL;DR: The present paper deals with 45 major new drugs that have been considered by the Committee on Safety of Medicines during the past eight or nine months, and it is of importance to know to what extent, in this series of drugs, toxic effects observed in the animal studies predicted the adverse effects that were observation in the clinical trials.
Journal ArticleDOI
Toxicological assessment of the hemostatic system, regulatory requirements, and industry practice
R. Theus,Gerhard Zbinden +1 more
TL;DR: In this review the physiology of hemostasis and the available laboratory tests are discussed, current regulatory requirements are described, and industry practice is analyzed based on experience accumulated over the last 23 years.
Book ChapterDOI
Cynomolgus Macaques as Models for Evaluating Effects of Contraceptive Steroids on Plasma Lipoproteins and Coronary Artery Atherosclerosis
TL;DR: The male female differences in deaths due to myocardial infarction in the United States in 1974 is summarized in Table 1.
Journal ArticleDOI
A review of regulatory risk assessment with formaldehyde as an example
TL;DR: The probability estimate that the substance is carcinogenic at typical ambient exposures multiplied by EPA's upper bound estimate is made from considerations of metabolism and pharmacokinetics, toxicology, short-term tests, animal tests, and epidemiology.
Journal ArticleDOI
Reducing uncertainty in risk assessment
TL;DR: This article presents a summary of the proceedings of the Symposium and Workshop on Reducing Uncertainty in Risk Assessment, held at Michigan State University, on May 18-19, 1987, and concluded that the increased understanding of underlying mechanisms of toxicity, gained in the last decade, should be incorporated as much as possible into the risk assessment process.