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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorTorres, Edgar
dc.contributor.authorAstacio González, Kristen
dc.date.accessioned2020-09-16T19:20:27Z
dc.date.available2020-09-16T19:20:27Z
dc.date.issued2015
dc.identifier.citationAstacio González, K. (2015). Shipping and transportation studies to evaluate drug product quality [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/684
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractMany pharmaceutical or biotechnological products require transport using temperature-controlled systems to maintain their therapeutic properties. There are presently no official guidelines for testing pharmaceutical products in order to define suitable transport specifications established by the FDA. After reviewing the current guidance documents, this study proposes a methodology to define appropriate transport conditions, while trying to keep competitive cost. This design project aims to provide a guideline to develop and design shipping & transportation studies. The design will consider critical factors such as transit time, transit routes, environmental conditions to evaluate that there is no effect on critical quality attributes (i.e., appearance and stability indicating analytical tests) of the evaluated/shipped product. Key Terms - Pharmaceutical Products, Temperature, Transport, Shipping & Transportation Studies.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Competitiveness;
dc.relation.ispartofseriesSpring-2015;
dc.relation.haspartSan Juanen_US
dc.subject.lcshPharmaceutical industry--Quality control
dc.subject.lcshShipping--Quality control
dc.subject.lcshPharmaceutical industry--Materials management
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleShipping and Transportation Studies to Evaluate Drug Product Qualityen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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