Therapeutic Drug Monitoring definition

Therapeutic Drug Monitoring or "TDM" contained in Section 1 (xxxxx) of the Agreement to read as follows :
Sample 1Sample 2Sample 3
Therapeutic Drug Monitoring. (or "TDM") shall mean the use of Antigen(s) solely for the purpose of [*] for an Active Immune Response Product and/or a Passive Immune Transfer Product that incorporates or is based on such Antigen(s), or for [*] such Active Immune Response Product and/or Passive Immune Transfer Product, as applicable, either during the [*] of such Active Immune Response Product and/or Passive Immune Transfer Product, as applicable, or following [*] thereof.
Sample 1Sample 2Sample 3
Therapeutic Drug Monitoring. OR "TDM" shall mean the use of a Marker(s) solely for the purpose of pre-screening human patients to determine eligibility for therapeutic treatment with an Active Response Product (as defined below) that incorporates such Marker(s) and/or a Passive Response Product (as defined below) that incorporates such Marker(s), or for [...***...] receiving such an Active Response Product and/or Passive Response Product, as applicable, either during the clinical phase of development of such Active Response Product and/or Passive Response Product, as applicable, or following commercialization thereof. For further clarification, use of a product is outside the Field if such product is associated commercially with Active Response Product and/or Passive Response Product administration and cannot be sold purely as a diagnostic product used for [...***...], [...***...] or [...***...] or for monitoring patient response to non-Active Response Product(s) or non-Passive Response Product(s). For purposes of this Agreement, "Active Response Product" shall mean a [...***...] containing [...***...], [...***...] presented in a [...***...] or as a [...***...]. For purposes of this Agreement, "Passive Response Product" shall mean an [...***...]a [...***...], or [...***...] to a [...***...] administered to patients [...***...] a [...***...].
Sample 1

Examples of Therapeutic Drug Monitoring in a sentence

  • Verstraete, "Detection times of drugs of abuse in blood, urine, and oral fluid," Therapeutic Drug Monitoring, vol.

  • Handbook of Analytical Therapeutic Drug Monitoring and Toxicology.

  • A second approach was to accept the aptness of the bank account analogy, and argue that it also ought not to be the subject of the criminal law.

  • Benchmarking Therapeutic Drug Monitoring Software: A Review of Available Computer Tools.

  • Intravenous Vancomycin Therapeutic Drug Monitoring in Children: Evaluation of a Pharmacy-Driven Protocol and Collaborative Practice Agreement.

  • Levofloxacin Dosing Regimen in Severely Morbidly Obese Patients (BMI ≥40 kg/m2) Should Be Guided by Creatinine Clearance Estimates Based on Ideal Body Weight and Optimized by Therapeutic Drug Monitoring.

  • The OPTIMAL TDM Study: Determining Optimal Beta-lactam Plasma Concentrations Through Therapeutic Drug Monitoring (OPTIMAL TDM).

  • Proceedings Of The Fifth International Congress Of Therapeutic Drug Monitoring And Clinical Toxicology, 20, 570-576.

  • Therapeutic Drug Monitoring Process at dshs.texas.gov/IDCU/disease/tb/forms/PDFS/TherapeuticDrugMonitori ngProcess.pdf.

  • Antiepileptic Drugs – Best Practice Guidelines for Therapeutic Drug Monitoring: A Position Paper by the Subcommission on Therapeutic Drug Monitoring, ILAE Commission on Therapeutic Strategies.


More Definitions of Therapeutic Drug Monitoring

Therapeutic Drug Monitoring means the use of Antigens solely for the purpose of [***]*.
Sample 1
Therapeutic Drug Monitoring means diagnostic uses limited solely to (a) patient qualification for treatment or prophylaxis with Licensed Product (e.g., testing to see whether the patient is infected with a virus to which the Licensed Antibody of the Licensed Product binds) and/or (b) patient monitoring in the course of treatment or prophylaxis with Licensed Product.
Sample 1
Therapeutic Drug Monitoring. (or "TDM") shall mean [***]. [***] indicates confidential treatment for omitted text has been requested
Sample 1

Related to Therapeutic Drug Monitoring

  • 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.

  • Therapeutic school means a residential group living facility:

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Therapeutic care means services provided by licensed or certified speech pathologists, Occupational Therapists and Physical Therapists.

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • 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.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • 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.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Drug means (i) articles or substances recognized in the official United States Pharmacopoeia

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Drug addiction means a disease characterized by a

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Automated drug dispensing system means a mechanical or electronic system that performs

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Biological diversity means the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems.

  • 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.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.