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 ?
At this time the project, which has been granted orphan status by the European Medicines Agency (EMA) and the US Food and Drug Agency (FDA), is in the preclinical development phase, with the manufacturing of early batches expected to begin shortly to support the required preclinical toxicology studies, which, once completed, will allow us to initiate the phase I/II clinical trial in 2015.
NYSE MKT: SYN), a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, announced today positive results from its final preclinical toxicology study of SYN-004.
PDS), an industry leader in providing preclinical toxicology, pathology, and repro/teratology software, in the development of an interface between Aperio's Spectrum[TM] digital pathology information management system and PathData[R], the PDS pathology software system.
Preclinical toxicology studies have shown that MRX-I is safe with very low tendency to induce myelosuppression, a common problem of many oxazolidinone antibiotics, including linezolid.
previously Director of Preclinical Toxicology for Lovelace and Director of Life Science Research and Development at Nektar Therapeutics, will serve as an independent consultant to the company, assisting in planning upcoming clinical trials and non clinical studies, and helping to prepare for eventual clinical trials of Homspera.
The grant will allow the selection of a lead compound to continue into preclinical toxicology testing for initial studies in humans.
Nasdaq: PCYC) today announced that further advancement of PCI-45292, a Btk inhibitor with exceptionally potent anti-arthritis activity in mice and rats, has been suspended following results from the current set of preclinical toxicology studies.
The company's services range from preclinical toxicology to Phase IV post-marketing surveillance.
The goals of the grant will be to first validate an orally administered ARD enhancer drug is efficacious in the SBMA transgenic animal model, and further, to complete preclinical toxicology, safety pharmacology, and ADME studies necessary in supporting of an IND filing to commence human clinical studies.
Headquartered in the US, Bridge provides preclinical toxicology studies in US & China with specialty capabilities in US to include developmental & reproductive toxicology (DART), safety pharmacology & vaccine development.
for the past 16 years, where he has provided expert advice and counsel in preclinical toxicology and clinical development of new drug products and medical devices.
Under the terms of the agreement, Polymun will use its proprietary cross-flow injector technology to manufacture ProNAi's liposome-formulated lead drug candidate, which is currently in the final stages of preclinical toxicology testing.