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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorCasiano Parrilla, Edgar
dc.date.accessioned2020-10-15T22:03:50Z
dc.date.available2020-10-15T22:03:50Z
dc.date.issued2013
dc.identifier.citationCasiano Parrilla, E. (2013). Reduction in dissolution test results variability of A/B capsule product [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/860
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractSince the origins of the agency, the Food and Drugs Administration (FDA), a scientific, regulatory, and public health agency had been dedicated to consumer protection. The FDA, provides standardized regulations and guidance to pharmaceutical industry. Under the agency umbrella are covered different organizations: The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to the people. The CDER works in the publication of diverse guidance for industry that include, scale up and post approval changes (SUPAC), testing of immediate release (IR) and modified release (MR) dosage forms, and the Investigation of Out-ofSpecification (OOS) Test Results for Pharmaceutical Production. Any failure or violations on drug products is considered to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)]and the current Good Manufacturing Practices (cGMP). Considering this, a recognized failure in dissolution testing is considered adulteration of the drug product with negative consequences to the manufacturing facility. Key Terms — Dissolution, Failure, Guidance, Requirements.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesWinter-2013;
dc.relation.haspartSan Juanen_US
dc.subject.lcshDrugs--Solubility--Testingen_US
dc.subject.lcshSix sigma (Quality control standard)
dc.subject.lcshPharmaceutical industry--Production control
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleReduction in Dissolution Test Results Variability of A/B Capsule Producten_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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