Validation Samples definition

Validation Samples means approximately (but not to exceed) […***…] abnormal biological samples, that comprise a representative subset of the total samples, that Sequenom used to validate the MaterniT21 PLUS Test, and including samples that are representative of the content that is identified in the latest version of the MaterniT21 PLUS Test immediately prior to the anticipated First Commercial Sale.
Sample 1

Examples of Validation Samples in a sentence

  • Model Parameter Estimates and Odds Ratios in the Medicare Development and Validation Samples 35Table 5.

  • General Considerations for Assay Validation Samples derived from pivotal studies should be tested with fully validated assays.

  • Risk-Adjustment Model Performance Summaries in the Medicare Development and Validation Samples 37Table 6.

  • In both the Development and Validation Samples, the average age of patients was 75.5, and the comorbidity frequencies were similar (Table 1).

  • Risk-Adjustment Model Performance Summaries in the Medicare Development and Validation Samples Characteristic2010 Development Split Sample2010 Validation Split Sample2011 Validation SampleYear Table 6.

  • After applying all inclusion and exclusion criteria, the Medicare FFS FY 2015 Dataset included 65,169 urology procedures performed at 1,062 ASCs. The Development and Validation Samples consisted of 45,619 and 19,550 urology procedures performed at 1,017 and 905 ASCs, respectively.

  • Cost28 per sample28 per sample$150 - 300 per samplen = 150 (includes QAQC)8000 (instrument)600 (instrument) 50 (supplies)50 (supplies) nalysis time = 5 days Validation Samples (20%)870 (labor@$86/hr for 40 hr) 500 (at $150/sample for n=30)870 (labor@$86/hr for 40 hr) 500 (at $150/sample for n=30) Cost444 per sample81 per sample Exclude Validation Cost414 per sample51 per sample Exclude Instrument Cost58 per sample58 per sample Exclude Instr.

  • The regression coefficients of the model variables were also stable across the Development and Validation Samples (Table 6).

  • Frequency of risk model variables in the Medicare Development and Validation Samples 34Table 2.

  • Model Parameter Estimates and Odds Ratios in the Medicare Development and Validation Samples Variable VariableTable 5.

Related to Validation Samples

  • Validation as used in WAC 222-20-016, means the department's agreement that a small forest landowner has correctly identified and classified resources, and satisfactorily completed a roads assessment for the geographic area described in Step 1 of a long-term application.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • Manufacturing Process means any process for—

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Samples mean representative physical examples of materials, equipment or workmanship, used to confirm compliance with requirements and/or to establish standards for use in execution of the Work.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Product Specifications means those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • labelling means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food;

  • API means the American Petroleum Institute.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Testing means that element of inspection that determines the properties or elements, including functional operation of materials, equipment, or their components, by the application of established scientific principles and procedures.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Drug use test means a scientifically substantiated method to test for the presence of illegal or performance-enhancing drugs or the metabolites thereof in a person’s urine.

  • DNA sample means any material that has come from a human body and consists of or includes human cells;

  • Batch Record means the production record pertaining to a Batch.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Contract Specifications means the principal trading terms in CFD (for example Spread, Swaps, Lot Size, Initial Margin, Necessary Margin, Hedged Margin, the minimum level for placing Stop Loss, Take Profit and Limit Orders, financing charges, charges etc) for each type of CFD as determined by the Company from time to time.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Assay means a laboratory analysis of Crude Petroleum to include the following: A.P.I. Gravity, Reid vapor pressure, composition, pour point, water and sediment content, sulfur content, viscosity, distillation, hydrogen sulfide, flash/boiling point and other characteristics as may be required by Carrier.

  • Stability means structural stability.