Dosage Form Development definition

Dosage Form Development means any pharmaceutical development activities for the Product that are necessary to design or modify a pharmaceutical formulation or dosage form to meet the desired clinical or commercial product profile, including in vitro studies on solubility, stability, physical and chemical characteristics, denaturation, particle formation, crystallization, micronization, excipient/material selection, compounding, mixing, casting, converting, drying, and similar activities.
Dosage Form Development means any pharmaceutical development activities for a Licensed Product that are necessary to design or modify a pharmaceutical formulation which includes formulation development, in vitro studies on solubility, stability, physical and chemical characteristics, denaturation, particle formation, crystallization, micronization, excipient selection, compounding, mixing, sterilization, filtration, quality assurance and control.
Dosage Form Development means any pharmaceutical development activities for the Product undertaken in order to design or modify a pharmaceutical formulation or dosage form to meet the desired clinical or commercial product profile, including in vitro studies on solubility, stability, physical and chemical characteristics, denaturation, particle formation, particle aggregation and settling, crystallization, micronization, excipient/material selection, compounding, mixing, casting, converting, drying, and similar activities. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

Examples of Dosage Form Development in a sentence

  • Notwithstanding anything to the contrary in this Agreement, in no event shall Codexis be obligated to [***] in conducting the Solid Dosage Form Development Study.

  • Commencing on the Commencement Date (as defined below) the Company shall employ the Employee for the Term (as herein defined), to render exclusive and full-time paid services (as herein defined) as the Company's Vice President of Modified Release Dosage Form Development.

  • Pages from Preformulation in Solid Dosage Form Development: Dissolution testing: Informa Healthcare USA, Inc.

  • Preformulation Considerations of Pharmaceutical Dosage Form Development - Case Study.

  • The Development Plan attached hereto as Exhibit A sets forth the details of the Development activities to be undertaken by Codexis pursuant hereto through the date of the Option Trigger and, thereafter in respect of the Solid Dosage Form Development Study, to the extent such Solid Dosage Form Development Study is not completed prior to the date of the Option Trigger.

  • ConstantinidesBiopharmaceutical & Drug Delivery Consulting, LLC., USAJason VaughnPatheon Pharmaceuticals, USA Track 1: Pre-formulation Considerations for Conventional Dosage Form Development Track 2: Formulation Aspects for Various Routes of Drug AdministrationTrack 3: Recent Technologies in Novel Drug Delivery SystemsGroup PhotoSession Chair: Panayiotis P.

  • Can-Fxxx will invite SKK’s input on Dosage Form Development, and will use good faith efforts to meet the needs of SKK in this regard, but Can-Fxxx shall have final decision-making authority regarding the tablet dosage form of the Product to be used outside of the Territory.

  • Notwithstanding anything to the contrary herein, Codexis shall [***] the Solid Dosage Form Development Study [***] that is [***] after the Effective Date.

  • KEY WORDSDrotaverine HCl, Bulk & Dosage Form, Development, Validation, RP-HPLC INTRODUCTIONDrotaverine hydrochloride is chemically known as 1- [(3, 4-[diethoxyphenyl) methylene]-6, 7 diethoxy-1, 2,3, 4 – tetra hydro isoquinolene hydrochloride [1].

  • The results of Dosage Form Development shall be disclosed to SKK promptly after completion of Dosage Form Development in writing and incorporated into the Licensed Technology or Data respectively.


More Definitions of Dosage Form Development

Dosage Form Development means any pharmaceutical development activities for the Product undertaken in order to design or modify a pharmaceutical formulation or dosage form to meet the desired clinical or commercial product profile, including in vitro studies on solubility, stability, physical and chemical characteristics, denaturation, particle formation, particle aggregation and settling, crystallization, micronization, excipient/material selection, compounding, mixing, casting, converting, drying, and similar activities.
Dosage Form Development shall have the meaning given in Section 3.1.
Dosage Form Development means any work relating to the formulation or composition of the Product. Endo shall pay Durect its documented, fully allocated development costs in connection with the performance of work under the Development Plan on a monthly basis, Net 30 days from the receipt of a correct invoice therefor from Durect; provided that Endo shall have no obligation to reimburse Durect’s costs in excess of the amount specified in the then-current Development Plan, and Durect shall have no obligation to perform activities which would result in Durect incurring costs in excess of the amount specified in then-current Development Plan until Endo has given prior approval in writing to increase the allowable amount for such activities under the Development Plan.
Dosage Form Development means any pharmaceutical development activities for the Product undertaken in order to design or modify a pharmaceutical formulation or dosage form to meet the desired clinical or commercial product profile, including in vitro studies on solubility, stability, physical and chemical characteristics, denaturation, particle formation, particle aggregation and settling, crystallization, micronization, excipient/material selection, compounding, mixing, casting, converting, drying, and similar activities. Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

Related to Dosage Form Development

  • 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.

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

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

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

  • Therapeutic school means a residential group living facility:

  • 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;

  • 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.

  • Formulation means the combination of various ingredients designed to render the product useful and effective for the purpose claimed, or the form of pesticide as purchased by users;

  • New development means development resulting from the conversion of previously undeveloped land or agricultural land uses.

  • Development Work means any work carried out in relation to the physical construction of a mine;

  • Development Plan has the meaning set forth in Section 3.2.

  • 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.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Licensed Process means a method, procedure, process, or other subject matter whose practice or use is Covered By any claim or claims included within the Patent Rights or uses Technology Rights.

  • Infill development means new construction on a vacant commercial lot currently held as open space.

  • cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epi­ dermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

  • 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;

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

  • 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:

  • 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.

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.