Therapeutic Drug Monitoring definition

Therapeutic Drug Monitoring or "TDM" contained in Section 1 (xxxxx) of the Agreement to read as follows :
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Therapeutic Drug Monitoring means the use of Antigens solely for the purpose of [***]*.
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Therapeutic Drug Monitoring. (or "TDM") shall mean [***]. [***] indicates confidential treatment for omitted text has been requested
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Examples of Therapeutic Drug Monitoring in a sentence

  • The Field of Therapeutic Drug Monitoring The Field of Therapeutic Drug Monitoring means the measurement of drug levels in patients in order to monitor their levels to achieve optimal therapy.

  • For each Product and Therapeutic Drug Monitoring Product, Zambon also agrees to make a written report to Corixa within ninety (90) days after the date on which Zambon, its Affiliates or sublicensees last sell that Product or Therapeutic Drug Monitoring Product stating in such report the same information required for quarterly reports of sales of all such Products or Therapeutic Drug Monitoring Products made, sold or otherwise disposed of which were not previously reported to Corixa.

  • These reports shall show for such calendar quarter sales by Zambon, its Affiliates and sublicensees of the Products or Therapeutic Drug Monitoring Products [***]*, Net Sales and the royalties and/or share of sublicense payments due to Corixa thereon pursuant to Article 7.

  • In addition, Zambon shall continue to pay all amounts payable hereunder with respect to Products and Therapeutic Drug Monitoring Products, if any, with respect to which this Agreement is not terminated.


More Definitions of Therapeutic Drug Monitoring

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 [...***...].
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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.
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Related to Therapeutic Drug Monitoring

  • Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.

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

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • 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;

  • 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 post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.

  • 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;

  • New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. § 601.2, or any equivalent or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the United States.

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

  • 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.