Matches in SemOpenAlex for { <https://semopenalex.org/work/W2065970511> ?p ?o ?g. }
Showing items 1 to 69 of
69
with 100 items per page.
- W2065970511 endingPage "194" @default.
- W2065970511 startingPage "189" @default.
- W2065970511 abstract "The FDA's Good Laboratory Practice Regulations (GLP) have been formally amended (once) and two formed advisory opinions have been issued. The FDA is now in the process of reviewing the GLPs to comply with both the Regulatory Flexibility Act of 1980 and Executive Order 12291 of 1981. Inspections since 1979 have revealed compliance progress; however, certain areas of the GLPs have been a problem--the definition of raw data, the documentation process for the maintenance of raw data, standard operating procedures, and study protocols. The increasing use of computers for supporting toxicology/pathology studies raises several questions concerning the impact of the GLPs on computerized data collection/reporting. This paper will address the above questions and discuss systems, procedures, interpretations, and some unresolved problems, as well as provide practical approaches for internal review of computer-supported nonclinical laboratory studies." @default.
- W2065970511 created "2016-06-24" @default.
- W2065970511 creator A5060330430 @default.
- W2065970511 date "1984-04-01" @default.
- W2065970511 modified "2023-09-27" @default.
- W2065970511 title "Inspection of Computer-Supported Toxicological Data Submitted to the FDA" @default.
- W2065970511 doi "https://doi.org/10.1177/009286158401800209" @default.
- W2065970511 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/10266895" @default.
- W2065970511 hasPublicationYear "1984" @default.
- W2065970511 type Work @default.
- W2065970511 sameAs 2065970511 @default.
- W2065970511 citedByCount "3" @default.
- W2065970511 crossrefType "journal-article" @default.
- W2065970511 hasAuthorship W2065970511A5060330430 @default.
- W2065970511 hasBestOaLocation W20659705111 @default.
- W2065970511 hasConcept C106436119 @default.
- W2065970511 hasConcept C111919701 @default.
- W2065970511 hasConcept C112930515 @default.
- W2065970511 hasConcept C132964779 @default.
- W2065970511 hasConcept C142724271 @default.
- W2065970511 hasConcept C162324750 @default.
- W2065970511 hasConcept C187736073 @default.
- W2065970511 hasConcept C199360897 @default.
- W2065970511 hasConcept C2522767166 @default.
- W2065970511 hasConcept C2778618615 @default.
- W2065970511 hasConcept C2780598303 @default.
- W2065970511 hasConcept C2781050149 @default.
- W2065970511 hasConcept C41008148 @default.
- W2065970511 hasConcept C56666940 @default.
- W2065970511 hasConcept C71924100 @default.
- W2065970511 hasConcept C98045186 @default.
- W2065970511 hasConceptScore W2065970511C106436119 @default.
- W2065970511 hasConceptScore W2065970511C111919701 @default.
- W2065970511 hasConceptScore W2065970511C112930515 @default.
- W2065970511 hasConceptScore W2065970511C132964779 @default.
- W2065970511 hasConceptScore W2065970511C142724271 @default.
- W2065970511 hasConceptScore W2065970511C162324750 @default.
- W2065970511 hasConceptScore W2065970511C187736073 @default.
- W2065970511 hasConceptScore W2065970511C199360897 @default.
- W2065970511 hasConceptScore W2065970511C2522767166 @default.
- W2065970511 hasConceptScore W2065970511C2778618615 @default.
- W2065970511 hasConceptScore W2065970511C2780598303 @default.
- W2065970511 hasConceptScore W2065970511C2781050149 @default.
- W2065970511 hasConceptScore W2065970511C41008148 @default.
- W2065970511 hasConceptScore W2065970511C56666940 @default.
- W2065970511 hasConceptScore W2065970511C71924100 @default.
- W2065970511 hasConceptScore W2065970511C98045186 @default.
- W2065970511 hasIssue "2" @default.
- W2065970511 hasLocation W20659705111 @default.
- W2065970511 hasLocation W20659705112 @default.
- W2065970511 hasOpenAccess W2065970511 @default.
- W2065970511 hasPrimaryLocation W20659705111 @default.
- W2065970511 hasRelatedWork W10687386 @default.
- W2065970511 hasRelatedWork W136152911 @default.
- W2065970511 hasRelatedWork W1591426632 @default.
- W2065970511 hasRelatedWork W1974195155 @default.
- W2065970511 hasRelatedWork W2494393505 @default.
- W2065970511 hasRelatedWork W2748952813 @default.
- W2065970511 hasRelatedWork W2805791621 @default.
- W2065970511 hasRelatedWork W2899084033 @default.
- W2065970511 hasRelatedWork W2987833367 @default.
- W2065970511 hasRelatedWork W4292258600 @default.
- W2065970511 hasVolume "18" @default.
- W2065970511 isParatext "false" @default.
- W2065970511 isRetracted "false" @default.
- W2065970511 magId "2065970511" @default.
- W2065970511 workType "article" @default.