Monotherapy definition

Monotherapy means a therapy in which the Drug Product is used as a sole anti-hepatitis C virus (HCV) agent.
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Monotherapy treatment of a condition by means of a single drug
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Monotherapy means a therapy using a Nektar Compound as an individual formulation for use in the Field.
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Examples of Monotherapy in a sentence

  • Monotherapy Activity ARTISTRY-1 Part B was designed to assess single-agent safety and antitumor activity in RCC and melanoma, two tumor types where high-dose rhIL-2 has shown monotherapy activity.

  • To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA) (SARIL-RA-ONE).

  • NT 219 Efficacy as Monotherapy Animal model Head & Neck Cancer (SCC - 9 ) NSG Ρ , PBMCs - injected 1 Drugs α - PD 1 Cetuximab (Erbitux®) NT 219 20 mg/kg NT 219 60 mg/kg 1 NSG mice were injected SC with SCC - 9 cells.

  • An Affiliate of M acting as toll packager pursuant to paragraph (f) below shall enter into one or more agreements with the Affiliate of S-P under which the M Affiliate shall furnish to the S-P QP such data and services regarding its operations as toll packager for the Ezetimibe Monotherapy Product as the S-P QP may reasonably require to discharge its responsibilities as a Qualified Person.

  • If a Right of Reference is necessary, each Party shall provide to the other a cross-reference letter or similar communication to the applicable Regulatory Authority if needed to effectuate the Right of Reference (including a Right of Reference to the Monotherapy Data solely to the extent necessary or useful in connection with regulatory approval of a Compound in the Combination).

  • For clarity, any Development of any Monotherapy Products conducted by the Parties after the PD-1 Effective Date shall be subject to Section 2.3.3. All reasonable Direct Costs incurred by either Party or its Affiliates in conducting (i) Development activities pursuant to a Development Plan, or (ii) Additional Studies that the Parties agree to conduct pursuant to this Section 2.3 following the PD-1 Effective Date shall be considered Development Costs.

  • Notwithstanding anything to the contrary herein, (a) MacroGenics shall have final decision-making authority with respect to commercial matters related to MacroGenics Pipeline Assets and, subject to the remainder of this Section 2.5(a), MacroGenics Combination Regimens, and (b) Incyte shall have final decision-making authority with respect to any matters related to the Monotherapy Regimen and any commercial matters related to the Licensed Product being sold in accordance with its approved label.

  • Jounce shall be responsible for Regulatory Interactions for any Monotherapy Product in the United States and any of its Non-Collaboration Combination Products anywhere in the Territory.

  • The Parties will seek to optimize the use of the E Monotherapy U.S. Trademark, the Z/E Combination Product U.S. Trademark and the M/E Combination Product U.S. Trademark in Canada, but only to the extent that the applicable Cholesterol Products are sold in Canada.

  • Monotherapy in Subjects with Moderate Hypercholesterolemia,” “A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Low Doses of the MTP-Inhibitor AEGR-733 on Hepatic Fat Accumulation as Measured by Magnetic Resonance Spectroscopy,” and “A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of the Combination of AEGR-733 and Atorvastatin 20 Mg vs.


More Definitions of Monotherapy

Monotherapy means the use or method of using a product comprising one (1) clinically or pharmacologically active ingredient as its sole active ingredient, and not in concomitant or sequential administration with any other product.
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Monotherapy means [***].
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Monotherapy means, with respect to a Licensed Product, that such Licensed Product is any of (a) labeled for use, (b) the subject of a Drug Approval Application for approval to be labeled for use or (c) the subject of a Phase 3 Clinical Trial for evaluation, in each case (clauses (a), (b) and (c)) by itself, without any other pharmaceutical product, to treat, prevent, cure or delay the progression of MDD.
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Monotherapy means, with respect to the Licensed Product for a given Indication, the intended use of such Licensed Product alone for such Indication, and not as part of a Combination Regimen (including concomitant or sequential therapy), either (a) in a Clinical Trial for such Licensed Product for such Indication as set forth in the protocol for such Clinical Trial or (b) for commercial sale for such Indication as set forth in the approved label for such Licensed Product. For clarity, use of the Licensed Product together with approved chemotherapy treatments shall be considered Monotherapy.
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Monotherapy means the delivery of Estradiol (or any other Estrogen added to the Field) using an MDTS, without delivering any other active ingredient using the MDTS. For clarity, delivery of Estradiol (or any other Estrogen added to the Field) using an MDTS, without delivering any other active ingredient using the MDTS, shall be considered Monotherapy notwithstanding any concurrent use or delivery of another active ingredient by a method other than spray delivery by the MDTS. For example, oral delivery of a progestin concurrently with delivery of Estradiol using the MDTS shall be considered Monotherapy.
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Related to Monotherapy

  • Therapy means the administration of drugs or chemicals to remove toxic concentrations of metals from the body.

  • Step therapy means a protocol or

  • Teletherapy means therapeutic irradiation in which the source of radiation is at a distance from the body.

  • Massage therapy means performance for compensation of massage, myotherapy, massotherapy, bodywork, bodywork therapy, or therapeutic massage including hydrotherapy, superficial hot and cold applications, vibration and topical applications, or other therapy which involves manipulation of the muscle and connective tissue of the body, excluding osseous tissue, to treat the muscle tonus system for the purpose of enhancing health, providing muscle relaxation, increasing range of motion, reducing stress, relieving pain, or improving circulation.

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

  • Brachytherapy means a method of radiation therapy in which sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, or interstitial application.

  • Gene Therapy means the introduction of a nucleic acid sequence encoding a protein intended for or otherwise conferring therapeutic benefit into a person for therapeutic purposes (i) by in vivo introduction for incorporation into cells of such person, or (ii) by ex vivo introduction into cells for transfer into a person.

  • Psychotherapy or "Therapy" means a goal directed process using generally accepted clinical approaches provided face-to-face by a qualified service provider with consumers in individual, group or family settings to promote positive emotional or behavioral change.

  • Moving beam radiation therapy means radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes arc, skip, conformal, intensity modulation and rotational therapy.

  • Prosthetic device means a replacement, corrective, or supportive device, other than contact lenses and dental prosthesis, dispensed pursuant to a prescription, including repair or replacement parts for that device, worn on or in the body to do 1 or more of the following:

  • Behavioral therapy means interactive therapies derived from evidence-based research, including applied behavior analysis, which includes discrete trial training, pivotal response training, intensive intervention programs, and early intensive behavioral intervention.

  • Diagnostic mammography means a method of screening that

  • Therapeutic school means a residential group living facility:

  • Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.

  • External beam radiation therapy means therapeutic irradiation in which the source of radiation is at a distance from the body.

  • Stray radiation means the sum of leakage and scattered radiation.

  • Prosthesis means an artificial substitute for a missing body part.

  • 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.

  • Radiation therapist means a person, other than a Licensed Practitioner or Nuclear Medicine Technologist, who applies radiation to humans for therapeutic purposes under the supervision of a Licensed Practitioner;

  • Fluoroscopic imaging assembly means a subsystem in which X-ray photons produce a visual image. It includes the image receptor(s) such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

  • Orthotic device means a custom-fitted or custom-fabricated medical device that is applied to a part of the human body to correct a deformity, improve function, or relieve symptoms of a disease.

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

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

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

  • Opioid antidote means any drug, regardless of dosage amount or method of administration, which has been approved by the United States Food and Drug Administration (FDA) for the treatment of an opioid overdose. “Opioid antidote” includes, but is not limited to, naloxone hydrochloride, in any dosage amount, which is administered through nasal spray or any other FDA-approved means or methods.