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Case Study: Recruitment Expertise Reduces High Screen Failure Rate
5/11/2011
The Quintiles team developed a profile of patients who would be more likely to fulfill criteria and distributed it to sites.
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Case Study: Advanced Prostate Cancer Phase III Study
5/11/2011
Two studies sought to evaluate the efficacy of the 15mg 4-month formulation or 22.5mg 6-month formulation in achieving castrate levels of testosterone (=1.735nmol/L) on Day 29 (i.e., 28 days after study drug injection).
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Advancing Vaccine Development
5/11/2011
With extensive experience in vaccines development, as well as market access and commercialization strategy, Quintiles is uniquely qualified to be your ally in vaccines.
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Case Study: Controlled Drug Handling
4/9/2010
A midsize pharmaceutical company came to Aptuit to work through the complexities of exporting a controlled substance manufactured in the United States and an EU-sourced comparator for inclusion in a clinical trial across more than 12 EU participating countries. Aptuit’s client was dealing with an Investigative Medicinal Product (IMP) manufactured in the United States and an EU-sourced comparator. By Aptuit, Inc.
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Poster: CMC For 505(b)(2) Applications
4/7/2010
The Chemistry, Manufacturing, and Control (CMC) Section (Modules 2 & 3 of the Common Technical Document [CTD]) of any application to the FDA will be the cornerstone for demonstrating the quality of any drug product. A clear document that complies with the ICH Harmonized Tripartite Guideline per the ICH Steering Committee Meeting (9 Nov 2000) is instrumental to that process. By Lynn Gold, PhD, Ken Phelps, Kathryn Wekselman, PhD, RN, and Karen Seta-Aust, PhD, Camargo Pharmaceutical Services, LLC
