FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3100813058> ?p ?o ?g. }

• W3100813058 abstract "Abstract Bioanalysis, a key supporting function for generating data for pre‐clinical and clinical studies in drug development, is under the regulation of local agencies as well as global organizations to ensure the data integrity and quality in submission. As major regulatory agencies and organizations, the US Food and Drug Administration, the European Medicines Agency and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use have been updating their industry guidance for bioanalytical method validation, to keep up with the development new modalities, technologies and regulations. This article summarizes the recent updates and any clarifications and controversies triggered by those updates. Perspectives and recommendations are given based on our own experience as well as commonly accepted practice in the bioanalytical community." @default.
• W3100813058 created "2020-11-23" @default.
• W3100813058 creator A5005339359 @default.
• W3100813058 creator A5061826377 @default.
• W3100813058 creator A5075716358 @default.
• W3100813058 creator A5081491694 @default.
• W3100813058 date "2020-12-09" @default.
• W3100813058 modified "2023-10-18" @default.
• W3100813058 title "Perspectives on updates, clarifications and controversies in chromatographic assay guidance for bioanalytical method validation from major regulatory agencies and organizations" @default.
• W3100813058 cites W1987980346 @default.
• W3100813058 cites W2011720547 @default.
• W3100813058 cites W2016907564 @default.
• W3100813058 cites W2016968987 @default.
• W3100813058 cites W2019140910 @default.
• W3100813058 cites W2029518949 @default.
• W3100813058 cites W2030049651 @default.
• W3100813058 cites W2068317785 @default.
• W3100813058 cites W2085831743 @default.
• W3100813058 cites W2088461157 @default.
• W3100813058 cites W2090380834 @default.
• W3100813058 cites W2147220328 @default.
• W3100813058 cites W2156296390 @default.
• W3100813058 cites W2939398473 @default.
• W3100813058 cites W2980357277 @default.
• W3100813058 cites W2985277946 @default.
• W3100813058 cites W3039350432 @default.
• W3100813058 cites W4212914796 @default.
• W3100813058 doi "https://doi.org/10.1002/bmc.5030" @default.
• W3100813058 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/33201529" @default.
• W3100813058 hasPublicationYear "2020" @default.
• W3100813058 type Work @default.
• W3100813058 sameAs 3100813058 @default.
• W3100813058 citedByCount "3" @default.
• W3100813058 countsByYear W31008130582022 @default.
• W3100813058 countsByYear W31008130582023 @default.
• W3100813058 crossrefType "journal-article" @default.
• W3100813058 hasAuthorship W3100813058A5005339359 @default.
• W3100813058 hasAuthorship W3100813058A5061826377 @default.
• W3100813058 hasAuthorship W3100813058A5075716358 @default.
• W3100813058 hasAuthorship W3100813058A5081491694 @default.
• W3100813058 hasConcept C108170787 @default.
• W3100813058 hasConcept C111472728 @default.
• W3100813058 hasConcept C112930515 @default.
• W3100813058 hasConcept C121332964 @default.
• W3100813058 hasConcept C127413603 @default.
• W3100813058 hasConcept C137535248 @default.
• W3100813058 hasConcept C138885662 @default.
• W3100813058 hasConcept C14036430 @default.
• W3100813058 hasConcept C144024400 @default.
• W3100813058 hasConcept C144133560 @default.
• W3100813058 hasConcept C17744445 @default.
• W3100813058 hasConcept C185592680 @default.
• W3100813058 hasConcept C24890656 @default.
• W3100813058 hasConcept C2779903281 @default.
• W3100813058 hasConcept C2779962950 @default.
• W3100813058 hasConcept C2780035454 @default.
• W3100813058 hasConcept C3018890749 @default.
• W3100813058 hasConcept C3019398576 @default.
• W3100813058 hasConcept C3116431 @default.
• W3100813058 hasConcept C36289849 @default.
• W3100813058 hasConcept C43617362 @default.
• W3100813058 hasConcept C55587333 @default.
• W3100813058 hasConcept C64903051 @default.
• W3100813058 hasConcept C71924100 @default.
• W3100813058 hasConcept C78458016 @default.
• W3100813058 hasConcept C86803240 @default.
• W3100813058 hasConcept C98274493 @default.
• W3100813058 hasConceptScore W3100813058C108170787 @default.
• W3100813058 hasConceptScore W3100813058C111472728 @default.
• W3100813058 hasConceptScore W3100813058C112930515 @default.
• W3100813058 hasConceptScore W3100813058C121332964 @default.
• W3100813058 hasConceptScore W3100813058C127413603 @default.
• W3100813058 hasConceptScore W3100813058C137535248 @default.
• W3100813058 hasConceptScore W3100813058C138885662 @default.
• W3100813058 hasConceptScore W3100813058C14036430 @default.
• W3100813058 hasConceptScore W3100813058C144024400 @default.
• W3100813058 hasConceptScore W3100813058C144133560 @default.
• W3100813058 hasConceptScore W3100813058C17744445 @default.
• W3100813058 hasConceptScore W3100813058C185592680 @default.
• W3100813058 hasConceptScore W3100813058C24890656 @default.
• W3100813058 hasConceptScore W3100813058C2779903281 @default.
• W3100813058 hasConceptScore W3100813058C2779962950 @default.
• W3100813058 hasConceptScore W3100813058C2780035454 @default.
• W3100813058 hasConceptScore W3100813058C3018890749 @default.
• W3100813058 hasConceptScore W3100813058C3019398576 @default.
• W3100813058 hasConceptScore W3100813058C3116431 @default.
• W3100813058 hasConceptScore W3100813058C36289849 @default.
• W3100813058 hasConceptScore W3100813058C43617362 @default.
• W3100813058 hasConceptScore W3100813058C55587333 @default.
• W3100813058 hasConceptScore W3100813058C64903051 @default.
• W3100813058 hasConceptScore W3100813058C71924100 @default.
• W3100813058 hasConceptScore W3100813058C78458016 @default.
• W3100813058 hasConceptScore W3100813058C86803240 @default.
• W3100813058 hasConceptScore W3100813058C98274493 @default.
• W3100813058 hasIssue "1" @default.
• W3100813058 hasLocation W31008130581 @default.
• W3100813058 hasOpenAccess W3100813058 @default.
• W3100813058 hasPrimaryLocation W31008130581 @default.
• W3100813058 hasRelatedWork W1537699525 @default.
• W3100813058 hasRelatedWork W2035298323 @default.

• next