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

  • 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.

  • 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.” ▇▇▇▇ ▇▇▇▇▇▇▇, PhD, President & COO, Otsuka Pharmaceutical Development & Commercialization, Inc., said, “Otsuka is delighted to be entering into this strategic relationship with GW.

  • During each phase of the development project, POLYPEPTIDE, will make a monthly status report to INTRABIOTICS by fax with originals by mail (Att.: Senior Director of Pharmaceutical Development).

  • Remit all payments to: Cardinal Health, Pharmaceutical Development, Somerset ▇.▇.

  • BEAUFOUR ▇▇▇▇▇ INDUSTRIE By: /s/ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇ ▇▇▇ Name: ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇ Title: CEO Vice-President, Pharmaceutical Development Multi-dose, ready to use Injection for administration using commercially available Pen injector, to deliver a fixed dose between 40-100mcg per day, with 28 days doses in 1.5ml cartridge.

  • We believe new gene transfer technology will lead the way in therapeutic response, outcomes and survival rates,” said ▇▇▇▇ ▇▇▇▇▇, PhD, Executive Vice President of Research and Pharmaceutical Development of Tocagen.

  • In addition, within ninety (90) days after the Amendment Effective Date, CDS shall provide to Alimera a Pharmaceutical Development Report, the form and content of which should follow the ICH Guidance documents Q8 Pharmaceutical Development (dated May 19, 2006) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008).

  • VARIAGENICS warrants that the NuCleave-TM- Reagents, if properly manufactured in accordance with specifications mutually agreed upon by VARIAGENICS and WATERS as set forth on Schedule 14.2 hereto (the "Specifications") and used in the Pharmaceutical Development Field in accordance with proper procedures on a NuCleave-TM- System, will identify genetic variations as specified in the product literature accompanying the Licensed Product.

  • WATERS shall have the right to extend such warranty to purchasers of NuCleave-TM- Kits for use on NuCleave-TM- Systems in the Pharmaceutical Development Field.

  • FibroGen shall report the progress of the items listed above to AstraZeneca’s appointed Pharmaceutical Development contacts on a regular and reasonable basis.

Related to Pharmaceutical Development

  • 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.

  • 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, 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).