Bioanalytical methods definition

Bioanalytical methods means methods based on the use of biological principles like cell-based assays, receptor- assays or immunoassays. They do not give results at the congener level but merely an indication (2) of the TEQ level, expressed in Bioanalytical Equivalents (BEQ) to acknowledge the fact that not all compounds present in a sample extract that produce a response in the test may obey all requirements of the TEQ-principle.
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Bioanalytical methods means methods based on the use of biological principles such as cell-based assays, receptor-assays or immunoassays. They do not give results at the congener level but merely an indication(9) of the TEQ level, expressed in Bioanalytical Equivalents (BEQ) to acknowledge the fact that not all compounds present in a sample
Sample 1Sample 2Sample 3

Examples of Bioanalytical methods in a sentence

  • Mr. Jannarone and Mr. Lysko discussed the additional state aid to be received for 2011-2012 school year.

  • Bioanalytical methods that may be useful for a better characterization of “unknown unknowns” are discussed in Section 6.

  • Bioanalytical methods are rapidly being developed to quantitatively monitor the transformation of ADCs in various in vitro or in vivo biological matrices such as serum/ plasma [190] and tumor tissues [191].

  • Bio-analytical methods to determine meropenem concentrations must be capable of evaluating the smallest possible sample volumes (preferably less than 100 microliters).

  • Bioanalytical methods are methods based on the use of biological principles like cell-based assays, receptor- assays or immunoassays.

  • Course Outcomes: Upon completion of the course, the student shall be able to understand• Extraction of drugs from biological samples• Separation of drugs from biological samples using different techniques• Guidelines for BA/BE studies UNIT IExtraction of drugs and metabolites from biological matrices: General need, principle and procedure involved in the Bioanalytical methods such as Protein precipitation, Liquid -Liquid extraction and Solid phase extraction and other novel sample preparation approach.

  • Bioanalytical methods are methods based on the use of biological principles like cell-based assays, receptor-assays or immunoassays.

  • Bioanalytical methods are methods based on the use of biological principles like cell- based assays, receptor-assays or immunoassays.

  • Bioanalytical methods for the measurement of EE and LNGThe performance results of the validated bioanalytical method for each analyte are summarized in Table 4.1-2.Table 4.1-2.

  • Bioanalytical methods are used for the quantitation of drugs and their metabolites in biological matrices.

Related to Bioanalytical methods

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • Analytical x-ray system means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.

  • API means the American Petroleum Institute.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • 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.

  • Interchangeable biological product means a biological product that the U.S. Food and Drug Administration has:

  • Manufacturing Process means any process for—

  • Diagnostic source assembly means the tube housing assembly with a beam-limiting device attached.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Testing laboratory means a laboratory, facility, or entity in the state that offers or performs tests of cannabis or cannabis products and that is both of the following:

  • Biological Materials means certain tangible biological materials that are necessary for the effective exercise of the Patent Rights, which materials are described on Exhibit A, as well as tangible materials that are routinely produced through use of the original materials, including, for example, any progeny derived from a cell line, monoclonal antibodies produced by hybridoma cells, DNA or RNA replicated from isolated DNA or RNA, recombinant proteins produced through use of isolated DNA or RNA, and substances routinely purified from a source material included in the original materials (such as recombinant proteins isolated from a cell extract or supernatant by non-proprietary affinity purification methods). These Biological Materials shall be listed on Exhibit A, which will be periodically amended to include any additional Biological Materials that Medical School may furnish to Company.

  • Siemens means Siemens AG (Germany) and its Affiliates.

  • Clean coal technology demonstration project means a project using funds appropriated under the heading “Department of Energy—Clean Coal Technology,” up to a total amount of $2,500,000,000 for commercial demonstration of clean coal technology, or similar projects funded through appropriations for the Environmental Protection Agency. The federal contribution for a qualifying project shall be at least 20 percent of the total cost of the demonstration project.

  • Analytical x-ray equipment means equipment used for x-ray diffraction or fluorescence analysis.

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

  • 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.

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • 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.

  • Hemp products means all products made from industrial hemp,