Preclinical when used with respect to studies or data refers to preliminary pharmacological studies undertaken in non-human animals, but not necessarily for purposes of submission in support of Regulatory Approval.
Preclinical means prior to the INITIATION of a first CLINICAL TRIAL by or on behalf of a LICENSEE, SUBLICENSEE, or AFFILIATE.
Preclinical means that a lead compound has been identified which Isis has determined is a candidate for commercial development. Preclinical development activities include pharmacology, toxicology and pharmacokinetic testing in preclinical models (in vitro and animal), formulation work and manufacturing scale-up in preparation for submission of the necessary data to comply with applicable regulations prior to commencement of human testing. In some cases, we are developing compounds, such as Vitravene(TM), to treat certain diseases for which no adequately predictive animal efficacy model exists. As a result, we may only conduct in vitro efficacy studies for such compounds, prior to testing the efficacy of the compounds in humans, and drug candidates for these diseases must progress to Phase II human clinical trials before we will have evidence of in vivo efficacy for such compounds. Preclinical development includes studies which may provide preliminary evidence of a compound's safety in animals but which may not, without additional testing, be sufficient to commence human clinical trials. Results obtained in preclinical studies are not necessarily indicative of results that will be obtained in later stages of preclinical development or in human clinical testing.
Examples of Preclinical in a sentence
Preclinical data on postnatal toxicity of adalimumab are not available (see section 5.3).
The list has six broad categories of scientific interest in cancer research.• Type of Research Study: Select the type from the drop-down list to indicate if the research project is "Clinical", "Pre-clinical", or “Health Services Research”.o If “Clinical” is selected, indicate the clinical trial phase and clinical trial number or identifier.• Assurances:o Animal Use.
Fertility Preclinical data on fertility effects of adalimumab are not available.
Refer to the Investigator’s Brochure for Preclinical and Clinical data.
Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient.
More Definitions of Preclinical
Preclinical means the stage prior to the manifestation of specified symptoms that facilitate the diagnosis of a disease or disorder.
Preclinical will mean in respect of procedures or research, animal or phantom procedures or other research not conducted on human subjects.
Preclinical means preliminary pharmacological studies undertaken in non-human animals, but not necessarily for purposes of submission in support of Regulatory Approval.
Preclinical means preliminary pharmacological studies undertaken in non-human animals, but not necessarily for purposes of submission in support of Regulatory Approval. Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Preclinical means that a lead compound is undergoing toxicology, formulation and other testing in preparation for clinical trials. Phase 1-3 clinical trials are safety and efficacy tests in humans as follows:
Preclinical refers to further testing of a defined product candidate IN VITRO and in animals prior to clinical studies.
Preclinical means any company with a product or product candidate that has not yet been tested in humans in a clinical setting;