Pharma Logistics Applications & Studies
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Case Study: Comprehensive Preclinical Development Program
4/9/2010
Aptuit was asked to conduct an extended package of preclinical studies within a short time frame. As the critical studies are dependent on the results of earlier work in the package (for example, initiation of the 28 day toxicology studies are dependent on the completion of bioanalytical method development, dose range finding, etc.) not only scheduling, but adherence to the schedule was the major risk to achievement of the overall aim, and on time filing to the regulator. By Aptuit, Inc.
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Comprehensive Preclinical Development Program
4/9/2010
Aptuit was asked to conduct an extended package of preclinical studies within a short time frame. As the critical studies are dependent on the results of earlier work in the package (for example, initiation of the 28 day toxicology studies are dependent on the completion of bioanalytical method development, dose range finding, etc.) not only scheduling, but adherence to the schedule was the major risk to achievement of the overall aim, and on time filing to the regulator. By Aptuit, Inc.
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Case Study: Product Development Of An Inhaled Protein
4/9/2010
A small biotechnology company in the United States turned to Aptuit to support the development of their inhaled respiratory product. They had added confidence that their limited in-house capability would benefit from Aptuit’s substantial experience and capabilities in respiratory science projects, fulfilling their need for first-in-class capabilities in manufacturing, clinical packaging and logistics, bio-analytics and respiratory analytics. By Aptuit, Inc.
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Product Development Of An Inhaled Protein
4/9/2010
A small biotechnology company in the United States turned to Aptuit to support the development of their inhaled respiratory product. They had added confidence that their limited in-house capability would benefit from Aptuit’s substantial experience and capabilities in respiratory science projects, fulfilling their need for first-in-class capabilities in manufacturing, clinical packaging and logistics, bio-analytics and respiratory analytics. By Aptuit, Inc.
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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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The Power Of Partnership: Supporting Rapid Global COVID-19 Manufacture
One company that developed a COVID-19 vaccine, shares the partnership that simplified tech transfer and helped them overcome challenges with analytical methods to meet their aggressive timelines.
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