Pediatric Formulation definition

Pediatric Formulation shall have the meaning set forth in Section 6.2(e). “Product” shall mean COBI Product, EVG Product, TAF Product, TDF Product, COBI Combination Product, EVG Combination Product, TAF Combination Product, TDF Combination Product, and the Quad Products.
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Pediatric Formulation shall have the meaning set forth in Section 6.2(e).
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Examples of Pediatric Formulation in a sentence

  • Licensee will have the right to develop a BIC Product or BIC Combination Product as either a liquid or dispersible tablet formulation for use in pediatric patients less than 12 years of age (such formulation shall be a Pediatric Formulation).

  • If Licensee is granted regulatory approval to market such Pediatric Formulation, then Licensee will use reasonable efforts to make such Pediatric Formulation available throughout the BIC Territory (for purposes of Section 6.2(e) of the Agreement, the BIC Territory shall be Licensee’s Applicable Territory with respect to such Pediatric Formulation).

  • Efficacy and Tolerability Outcomes of a Phase II, Randomized, Open-Label, Multicenter Study of a New Water-Dispersible Pediatric Formulation of Dihydroartemisinin-Piperaquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in African Infants.

  • Pediatric Formulation Development232233 This section should provide details of any pediatric-specific formulation development plans, if234 appropriate, including whether the formulation that is being developed can be used for all235 pediatric populations (1 to 3 pages).

  • Gilead shall have the right to sublicense such Pediatric Formulation to Japan Tobacco for use in Japan in accordance with the Japan Tobacco Agreement.

  • Long-term Serologic Follow-up of Children Vaccinated with a Pediatric Formulation of Virosomal hepatitis A Vaccine Administered With Routine Childhood Vaccines at 12-15 Months of Age.

  • TI-LAN-Upgrade_Diagram.pdf Frontrunner Proposal 2.28.19.pdf TICSD_Preliminary_SMART_Plan.pdf 5b.Enter the webpage address where the final Smart Schools Investment Plan is posted.

  • The United States Pediatric Formulation Initiative (US-PFI) is a project of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

  • Summary of the National Institute of Child Health and Human Development–Best Pharmaceuticals for Children Act Pediatric Formulation Initiatives Workshop–Pediatric Biopharmaceutics Classification System Working Group.

  • The record amply supports the district court’s use of earning capacity rather than actual income.

Related to Pediatric Formulation

  • 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.

  • Biological agent shall mean any pathogenic (disease producing) micro-organism(s) and/or biologically produced toxin(s) (including genetically modified organisms and chemically synthesized toxins) which cause illness and/or death in humans, animals or plants.

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

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

  • Pharmaceutical means any compound or mixture, other than food, used in the prevention, diagnosis, alleviation, treatment, or cure of disease in human and animal.

  • 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.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Therapeutic school means a residential group living facility:

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

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

  • 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.

  • 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;

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Diagnostic mammography means a method of screening that

  • 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;

  • Interchangeable biological product means a biological product that the federal Food and Drug Administration has:

  • 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.

  • Compounds means a small molecule HMT inhibitor.

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

  • 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.