preclinical toxicology


Also found in: Acronyms.

preclinical toxicology (prēˈ·kliˑ·ni·kl tksˈ··kˑ·l·jē),

n studies of the toxicology of a substance on animals and cells to prepare parameters for Phase I human subject clinical studies. These include determination of acute, subacute, and chronic toxicity, carcinogenicity, mutagenicity, teratogenicity, and effects on the reproductive system.
References in periodicals archive ?
Visterra said that the BARDA contract includes funding for performing preclinical toxicology studies, conducting clinical trials, manufacturing of materials for clinical trials and continued optimization of manufacturing processes, and associated regulatory activities intended to advance VIS410.
Biotechnology company Synthetic Biologics (NYSE MKT:SYN) said on Tuesday that it has received encouraging results from its final preclinical toxicology study of SYN-004 to prevent the devastating effects of Clostridium difficile (C.
Steve Snyder is a consultant with more than 25 years of experience in preclinical toxicology as an outsourcing customer and provider.
After graduation he was an assistant professor in the School of Pharmacy at Washington State University for one year before deciding to enter the world of preclinical toxicology contract research, where he has held numerous scientific and leadership positions over the past 34 years.
Conduct of successful preclinical toxicology trials on CSSK in cynomolgus monkeys.
By Steve Snyder Contributing Editor Steve Snyder is a consultant with more than 25 years of experience in preclinical toxicology as an outsourcing customer and provider.
PM060184 is a marine-derived synthetically-produced compound which has shown strong in vitro and in vivo antitumor activity and a favorable safety profile in preclinical toxicology studies.
The company has renovated space at its preclinical toxicology site in Evansville, Ind.
The webinar entitled Preclinical Toxicology - Is There a Better Model in Type 2 Diabetes?
At the pre-NDA meeting, the FDA was asked to confirm that the preclinical toxicology package for DM-1796 was sufficient.
Preclinical toxicology and biodistribution regulatory studies are in progress and will allow the submission of the regulatory file for a phase I clinical trial planned in 2009 in metastatic melanoma patients.
of Preclinical Toxicology Programs for Approved Biopharmaceuticals Science and Judgment in Establishing a Safe Starting Dose for First-in-Human Trials of Biopharmaceuticals