Pharmaceutical Development definition

Pharmaceutical Development means the design, Development, Manufacturing and optimization of medicinal products for use in Clinical Studies and Commercialization; including drug substance and drug product and device Manufacturing processes, primary packaging, quality standards, stability testing, pre-First Commercial Sale engineering and conformance, CMC documentation and technology transfer to operations.
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Pharmaceutical Development means and include all tasks and activities performed for the purpose of obtaining CMC (Chemistry, Manufacturing & Controls) Development Data suitable for regulatory approval, and a robust and economical manufacturing process capable of meeting quality control targets at commercial production volumes. As such, it includes, but is not limited to the activities of process and formulation development, scale-up trials and production of drug materials for use in clinical trials, equipment and process validation, qualification of materials, stability and compatibility testing of the API and Drug Product, as well as development and validation of analytical methodology necessary to process validation and product release testing.
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Examples of Pharmaceutical Development in a sentence

  • They will be focused on enhancing knowledge on matters dealt with in the CSCE among, inter alia, civil servants, the media and the public at large.

  • Pharmaceutical Development Agreement by and between the Corporation and Ipsen, dated January 2, 2006, as amended by Amendment No. 1, dated January 1, 2007, Amendment No. 2, dated January 1, 2009, and Amendment No. 3, dated June 16, 2010.

  • This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies and Commercial supply of APIs and Finished dosage forms.

  • The Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors.

  • Bruce Connop, PhD, currently Vice President, Non-Clinical & Pharmaceutical Development, of Transition Therapeutics Inc., a subsidiary of OPKO Health, Inc., has experience in pharmaceutical API production and pre-clinical development.

  • However, one of the objectives in the Health Development Plan’s Program for Pharmaceutical Development is to transform the DNME into an autonomous National Institute for the Regulation of Pharmaceuticals and Health Products by 2015, to serve as the national regulatory authority.

  • Such Investor understands that the Corporation is relying upon the representations and agreements contained in this Agreement (and any supplemental information) for the purpose of determining whether this transaction meets the requirements for such exemptions.

  • We are delighted to be working with Otsuka to fulfill our ambition of developing a range of novel cannabinoid medicines to meet serious unmet medical needs.” Xxxx Xxxxxxx, PhD, President & COO, Otsuka Pharmaceutical Development & Commercialization, Inc., said, “Otsuka is delighted to be entering into this strategic relationship with GW.

  • Experimental approaches; in: Toward a less harmful cigarette, Pro- ceedings of Workshop on Smoking and Health, September, 1967, edited by E.L. Wynder and D.

  • Five-year goal:• Support the Canadian dairy industry in its adaptation to the new environment brought about by new international trade agreements.

Related to Pharmaceutical Development

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, multi-apartment buildings, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • 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.

  • Pharmaceutical care means the provision of drug therapy and

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

  • Pharmaceutical means a drug intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or animals.

  • Research and development means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

  • Professional development means training programs for

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

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

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • Residential Development means lands, buildings or structures developed or to be developed for residential use;

  • Radiopharmaceutical means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

  • Economic development means all powers expressly granted and reasonably inferred pursuant to SDCL § 9-54.

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • Medical management technique means a practice which is used to control the cost or utilization of health care services or prescription drug use. The term includes, without limitation, the use of step therapy, prior authorization or categorizing drugs and devices based on cost, type or method of administration.

  • spatial development framework means the Kouga Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

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

  • Substantial development means any development of which the total cost or fair market value exceeds two thousand five hundred dollars, or any development which materially interferes with the normal public use of the water or shorelines of the state; except that the following shall not be considered substantial developments for the purpose of this chapter:

  • 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:

  • 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;

  • 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.

  • Planned development means a real property development other than a community apartment project, a condominium project, or a stock cooperative, having either or both of the following features:

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • Biotechnology means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.