Assay Development definition

Assay Development means the development of the Assay (including software development), the technical validation and verification of the RMS Product, Clinical Validation, clinical reproducibility studies of the RMS Product, the manufacturability of the RMS Product and preparing and submitting to the Regulatory Authorities applications for, and obtaining and maintaining, Regulatory Approvals for the RMS Product.
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Assay Development. Scopus Biopharma will contract with a Contract Research Organization (CRO) to develop and validate bioanalytical methods for rat, dog, and human plasma. Pharmacology: Scopus Biopharma will contract with qualified CRO(s) to perform standard Good Laboratory Practice (GLP) safety pharmacology studies. The studies will include in vitro hERG, subcutaneous (sc) rat central nervous system, sc rat respiratory system, and sc dog cardiovascular system, as well as additional studies if warranted by the data. All of the GLP safety pharmacology studies will utilize DS from either the engineering or cGMP batches.
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Assay Development means the activities to be carried out by Aptuit to develop, optimize or adapt an Assay to the Aptuit Technology as more particularly described in the Project Description(s).
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Examples of Assay Development in a sentence

  • From 2002 to 2010 Dr Jarolimek was Director of Assay Development and Compound Profiling at the GlaxoSmithKline Center of Excellence in Drug Discovery in Verona, Italy.

  • Students traveling to and from school come under the jurisdiction of the school authorities.

  • See www.perkinelmer.com/AlphaPlex for more information about the AlphaPlex technology and download the “AlphaPlex Quick Start Guide” and the “AlphaPlex Assay Development Guide” to find guidance about filters and mirrors selection, instrument protocol and channels crosstalk correction.

  • We thank the Gladstone Light Microscopy and Histology Core, the Gladstone Assay Development and Drug Discovery Core, and the Gladstone Stem Cell Core for their support and experimental expertise.

  • Azerbaijani media portray Armenians as sub-humans capable of all evils.

  • Chapter Eight - Second-Harmonic Generation (SHG) for Conformational Measurements: Assay Development, Optimization, and Screening, in Modern Approaches in Drug Discovery, ed.

  • In November 2016, we entered into a Master Assay Development, Commercialization and Manufacturing Agreement (the “Governing Agreement”) with QIAGEN Manchester Limited (“QML”), a wholly owned subsidiary of QIAGEN N.V. in the field of oncology.

  • Advanced Assay Development Guidelines for Image-Based High Content Screening and Analysis.

  • This database was custom-designed for the management of CDC Assay Development and Diagnostic Reference Laboratory (ADDRL) test results, and functions within SQL Server software (Microsoft, Redmond, WA) with a .NET (Microsoft, Redmond, WA) user interface.Reporting is done directly from the database in printed form or by electronic transfer.

  • Guidance for Industry Assay Development for Immunogenicity Testing of Therapeutic Proteins.


More Definitions of Assay Development

Assay Development means the process of creating reproducible and quantitative assays, as well as ascertaining pre-analytical variables that affect reproducibility such that the test can be run in a clinical laboratory.
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Assay Development. Licensee will contract with a Contract Research Organization (CRO) to develop and validate bioanalytical methods for rat, dog, and human plasma. Assay development will be concurrent with DS and DP development and manufacture and cost will be approximately [ ]. A-034-2016 CONFIDENTIAL NIH Patent License Agreement—Exclusive
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Assay Development. Licensee will contract with a Contract Research Organization (CRO) to develop and validate bioanalytical methods for rat, dog, and human plasma. Assay development will be concurrent with DS and DP development and manufacture and cost will be approximately [ ]. A-034-2016 CONFIDENTIAL NIH Patent License Agreement—Exclusive PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED AND ARE SUBJECT TO A CONFIDENTIAL INFORMATION REQUEST FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Pharmacology: In addition to the nonclinical primary pharmacodynamic (PD) studies in scleroderma models that will be conducted under the CRADA, VS will contract with qualified CRO(s) to perform standard Good Laboratory Practice (GLP) safety pharmacology studies. The studies will include in vitro hERG, oral rat central nervous system, oral rat respiratory system, and oral dog cardiovascular system, as well as additional studies if warranted by the data. All of the GLP safety pharmacology studies will utilize DS from either the engineering or cGMP batches. Pharmacokinetics: Licensee will contract with qualified CRO(s) to perform various in vitro pharmacokinetic (PK) studies, including metabolic stability studies, drug-drug interaction studies, protein binding studies, and permeation studies. These studies will be initiated early on and will use DS from the scale up efforts. The data package for MRI-1867 includes results that fit into these categories of studies. Depending on the availability of the corresponding study reports (i.e., for Licensee to use in an IND submission), the study designs, and the comparability of the test material used, Licensee may be able to use some of the NIH results in lieu of conducting such studies. Once the engineering batch DS is available, Licensee will contract with qualified CRO(s) to perform oral rat single dose PK, oral dog single dose PK, and absolute bioavailability. Radiolabeled MRI-1867 will be used for mass balance and tissue distribution studies. Additional nonclinical absorption, distribution, metabolism, and excretion (ADME) studies will be contracted as warranted by the data.
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Assay Development means the activities to be carried out by Evotec to develop, optimize or adapt an Assay to the Evotec Technology as more particularly described in the Project Description(s).
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Assay Development means the Formatting of each individual SNP into a working assay through the custom design and testing of specific oligonucleotides for the interrogation of an individual SNP, including one set of PCR Primers and one SNP-IT Primer for the desired SNP, in conjunction with Genotyping against a known sample set.
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Related to Assay Development

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • Infill development means new construction on a vacant commercial lot currently held as open space.

  • Economic development means all powers expressly granted and reasonably inferred pursuant to SDCL § 9-54.

  • Major development means an individual “development,” as well as multiple developments that individually or collectively result in:

  • Planned development means a real property development other than a community apartment project, a condominium project, or a stock cooperative, having either or both of the following features:

  • Development means any man-made change to improved or unimproved real estate, including, but not limited to, buildings or other structures, mining, dredging, filling, grading, paving, excavation or drilling operations, or storage of equipment or materials.

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Substantial development means any development of which the total cost or fair market value exceeds two thousand five hundred dollars, or any development which materially interferes with the normal public use of the water or shorelines of the state; except that the following shall not be considered substantial developments for the purpose of this chapter:

  • Research and development means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

  • spatial development framework means the Kouga Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • Existing development means development, other than that associated with agricultural or forest management activities, that meets one of the following criteria:

  • Residential Development means lands, buildings or structures developed or to be developed for residential use;

  • New development means development resulting from the conversion of previously undeveloped land or agricultural land uses.

  • Mixed use development means a Building used, designed or intended for Residential and Non-Residential uses, where:

  • Cluster development means a contiguous cluster or

  • Planned unit development means a subdivision characterized by a unified site design, clustered residential units and/or commercial units, and areas of common open space.

  • Housing development as used in this section, means a development project for five or more residential units, including mixed-use developments. For the purposes of this section, “housing development” also includes a subdivision or common interest development, as defined in Section 4100 of the Civil Code, approved by a city, county, or city and county and consists of residential units or unimproved residential lots and either a project to substantially rehabilitate and convert an existing commercial building to residential use or the substantial rehabilitation of an existing multifamily dwelling, as defined in subdivision (d) of Section 65863.4, where the result of the rehabilitation would be a net increase in available residential units. For the purpose of calculating a density bonus, the residential units shall be on contiguous sites that are the subject of one development application, but do not have to be based upon individual subdivision maps or parcels. The density bonus shall be permitted in geographic areas of the housing development other than the areas where the units for the lower income households are located.

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Economic development project means land and existing or planned improvements suitable for use by an industrial or commercial enterprise, or housing development, or the protection of the environment, including, but not limited to, groundwater or surface water. Economic development project includes necessary buildings, improvements, or structures suitable for and intended for or incidental to use as an industrial or commercial enterprise or housing development; and includes industrial park or industrial site improvements and port improvements or housing development incidental to an industrial or commercial enterprise; and includes the machinery, furnishings, and equipment necessary, suitable, intended for, or incidental to a commercial, industrial, or residential use in connection with the buildings or structures.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • sustainable development means development which meets the needs of the present without compromising the ability of future generations to meet their own needs.

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • Professional development means training programs for

  • Medical management technique means a practice which is used to control the cost or utilization of health care services or prescription drug use. The term includes, without limitation, the use of step therapy, prior authorization or categorizing drugs and devices based on cost, type or method of administration.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.