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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorRodríguez Cortés, David E.
dc.date.accessioned2020-09-16T15:35:45Z
dc.date.available2020-09-16T15:35:45Z
dc.date.issued2015
dc.identifier.citationRodríguez Cortés, D. E. (2015). Development and optimization for generic capsule solid oral dosage formulation using quality by design (QbD) principles [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/610
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractTraditionally, the development and formulation of generic drugs has focused on the delivery of the product to the next phase of clinical study making the formulation design iterative and empirical. Furthermore, pharmaceutical companies have ensured quality and performance on their product by raw material testing, in-process material testing and end product testing. This traditional approach has induced a knowledge gap in understand the relationship between product quality attributes and their clinical performance. As a result of this approach, regulatory bodies are encouraging the generic companies to include QbD elements in their filling applications with the intention of improve their process understanding. This project design presents an overview of implementation of key elements of Quality by Design to develop a pharmaceutical formula for a generic product. Key Terms - Critical Quality Attributes, Design of Experiment, Quality by Design, Quality Risk Management, Quality Target Product Profileen_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesFall-2015;
dc.relation.haspartSan Juanen_US
dc.subject.lcshPharmaceutical industryen_US
dc.subject.lcshDrugs--Dosage forms
dc.subject.lcshDrugs--Design
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleDevelopment and Optimization for Generic Capsule Solid Oral Dosage Formulation Using Quality by Design (QbD) Principlesen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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