non-clinical study

non-clinical study

A generic term for any study—e.g., biochemical, Drosophila, rodent, etc.— not performed on human subjects.
References in periodicals archive ?
Pomezia, Italy, June 28, 2019 - Menarini Ricerche today announced the publication of the results of a non-clinical study describing the characterization of the anti-CD205 Antibody-Drug Conjugate (ADC) MEN1309/OBT076.
The results from this non-clinical study will be highlighted in a poster presentation.
In a non-clinical study where mouse models were inoculated with mouse liver cancer, melanoma or colon cancer cell lines and treated with a combinartion of lenvatinib with an anti-mouse PD-1 antibody, synergistic anti-tumor activities were demonstrated.4 These are thought to be a result of an immunostimulatory response through a reduction in immunosuppressive tumor-associated macrophages and an increase in cytotoxic T lymphocytes by lenvatinib.
The GLP principles are a quality program related to organizational processes and experimental conditions, required for a non-clinical study to be accepted in the main international regulatory agencies (80).
Our data support the recommendation of conducting a non-clinical study that compares both PK and immunogenicity responses to comprehensively assess biosimilarity prior to initiating a costly and lengthy clinical study.
An IIT may be a clinical or non-clinical study and is conducted without the participation of Novartis, where the sponsor of the IIT makes a request to Novartis to provide either funding, drug product or both.
This approval was based on FDA's review of the company's Manufacturing and Non-Clinical Study Protocols, supporting the Building 55 comparability programme.
In a non-clinical study where mouse models were inoculated with mouse liver cancer, melanoma or colon cancer cell lines and treated with a combination of lenvatinib with an anti-mouse PD-1 antibody, synergistic anti-tumor activity was demonstrated, based on an immunostimulatory response due to the reduction in tumor associated macrophages and the enhancement of the ratio of memory T cells by lenvatnib.
We are targeting a rolling submission to FDA of the sBLA, including data from Chemistry, Manufacturing and Controls by early next year, followed by data from this pivotal non-clinical study later in 2015."
10 November 2011 - Japan's Kowa Company Ltd said on Wednesday that it will present the results of two Phase II studies and a non-clinical study of K-134, a therapeutic agent for peripheral arterial disease, at the American Heart Association Scientific Sessions 2011 from 12 to 16 November in Orlando, Florida.
Moreover, in a recent survey of large pharma executives conducted by Tufts CSDD, seven out of nine companies reported that they regularly outsource non-clinical study tasks, primarily toxicology and PK studies.
10 May 2011 - Japan's Kowa Company Ltd reported on Monday results of two clinical studies and a non-clinical study of a drug candidate for glaucoma and ocular hypertension (K-115).
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