Matches in SemOpenAlex for { <https://semopenalex.org/work/W2004682842> ?p ?o ?g. }
Showing items 1 to 79 of
79
with 100 items per page.
- W2004682842 endingPage "258" @default.
- W2004682842 startingPage "249" @default.
- W2004682842 abstract "To evaluate variability in drug dissolution testing 28 laboratories analyzed USP calibrators, US FDA prednisone tablets and a marketed glibenclamide tablet product. The experiments were conducted using paddle and basket methods at 50 (calibrators) and 75 (glibenclamide) rpm. The media employed were deaerated by equilibrating at 37 degrees C for 24 h and by the USP recommended method. The 95% CI values for percent drug release for the USP calibrator tablets were similar to the reported tolerances for the USP Acceptance Ranges; however, individual results from 15 of 28 laboratories suggest that the apparatus would not comply with the USP Apparatus Suitability Criteria. For FDA prednisone calibrator tablets, percent drug release using equilibrated medium was different (P=0.003) than by the USP recommended method. For the glibenclamide tablet results, a CV of 14-37% was observed, depending upon the sampling time and the type of apparatus employed. The results indicate that failure to meet the USP Dissolution Apparatus Suitability Test may not truly mean that the apparatus is 'out of compliance'. Due to the high variability in dissolution testing, in many cases the impact of formulation or manufacturing changes on drug release characteristics may not be observed, in particular with multi-point profiles." @default.
- W2004682842 created "2016-06-24" @default.
- W2004682842 creator A5026509873 @default.
- W2004682842 creator A5091850136 @default.
- W2004682842 date "1999-02-01" @default.
- W2004682842 modified "2023-10-13" @default.
- W2004682842 title "Typical variability in drug dissolution testing: study with USP and FDA calibrator tablets and a marketed drug (glibenclamide) product" @default.
- W2004682842 cites W181212721 @default.
- W2004682842 cites W1968557592 @default.
- W2004682842 cites W2045709813 @default.
- W2004682842 cites W2064899933 @default.
- W2004682842 cites W2069862547 @default.
- W2004682842 cites W2071541842 @default.
- W2004682842 cites W2111431523 @default.
- W2004682842 cites W2132139249 @default.
- W2004682842 cites W2139980668 @default.
- W2004682842 doi "https://doi.org/10.1016/s0928-0987(98)00034-7" @default.
- W2004682842 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/9845813" @default.
- W2004682842 hasPublicationYear "1999" @default.
- W2004682842 type Work @default.
- W2004682842 sameAs 2004682842 @default.
- W2004682842 citedByCount "68" @default.
- W2004682842 countsByYear W20046828422012 @default.
- W2004682842 countsByYear W20046828422013 @default.
- W2004682842 countsByYear W20046828422014 @default.
- W2004682842 countsByYear W20046828422015 @default.
- W2004682842 countsByYear W20046828422016 @default.
- W2004682842 countsByYear W20046828422017 @default.
- W2004682842 countsByYear W20046828422018 @default.
- W2004682842 countsByYear W20046828422020 @default.
- W2004682842 crossrefType "journal-article" @default.
- W2004682842 hasAuthorship W2004682842A5026509873 @default.
- W2004682842 hasAuthorship W2004682842A5091850136 @default.
- W2004682842 hasConcept C134018914 @default.
- W2004682842 hasConcept C14029885 @default.
- W2004682842 hasConcept C147789679 @default.
- W2004682842 hasConcept C185592680 @default.
- W2004682842 hasConcept C2779768347 @default.
- W2004682842 hasConcept C2780035454 @default.
- W2004682842 hasConcept C2781430271 @default.
- W2004682842 hasConcept C43617362 @default.
- W2004682842 hasConcept C555293320 @default.
- W2004682842 hasConcept C71924100 @default.
- W2004682842 hasConcept C88380143 @default.
- W2004682842 hasConcept C98274493 @default.
- W2004682842 hasConceptScore W2004682842C134018914 @default.
- W2004682842 hasConceptScore W2004682842C14029885 @default.
- W2004682842 hasConceptScore W2004682842C147789679 @default.
- W2004682842 hasConceptScore W2004682842C185592680 @default.
- W2004682842 hasConceptScore W2004682842C2779768347 @default.
- W2004682842 hasConceptScore W2004682842C2780035454 @default.
- W2004682842 hasConceptScore W2004682842C2781430271 @default.
- W2004682842 hasConceptScore W2004682842C43617362 @default.
- W2004682842 hasConceptScore W2004682842C555293320 @default.
- W2004682842 hasConceptScore W2004682842C71924100 @default.
- W2004682842 hasConceptScore W2004682842C88380143 @default.
- W2004682842 hasConceptScore W2004682842C98274493 @default.
- W2004682842 hasIssue "3" @default.
- W2004682842 hasLocation W20046828421 @default.
- W2004682842 hasLocation W20046828422 @default.
- W2004682842 hasOpenAccess W2004682842 @default.
- W2004682842 hasPrimaryLocation W20046828421 @default.
- W2004682842 hasRelatedWork W1971957888 @default.
- W2004682842 hasRelatedWork W2014152768 @default.
- W2004682842 hasRelatedWork W2035843972 @default.
- W2004682842 hasRelatedWork W2092267554 @default.
- W2004682842 hasRelatedWork W2104438858 @default.
- W2004682842 hasRelatedWork W2323215899 @default.
- W2004682842 hasRelatedWork W2323797364 @default.
- W2004682842 hasRelatedWork W2392659217 @default.
- W2004682842 hasRelatedWork W2394297123 @default.
- W2004682842 hasRelatedWork W4211011431 @default.
- W2004682842 hasVolume "7" @default.
- W2004682842 isParatext "false" @default.
- W2004682842 isRetracted "false" @default.
- W2004682842 magId "2004682842" @default.
- W2004682842 workType "article" @default.