Matches in SemOpenAlex for { <https://semopenalex.org/work/W2965972649> ?p ?o ?g. }
- W2965972649 endingPage "124" @default.
- W2965972649 startingPage "117" @default.
- W2965972649 abstract "Abstract The basic components of regulatory and supporting policies for orphan drug development appear similar between the United States and Japan, but drugs designated as orphan drugs have been different between the 2 countries. The probabilities of development success (ie, marketing approval) in designated orphan drugs have also been significantly different. In this study, we analyzed recent outcomes of development for orphan drugs designated from 1993 to 2017 in Japan, considering their development and approval status in the United States. Our analysis showed that success for orphan drug development in Japan was apparently associated with prior approval status in the United States. Company size, orphan development experience, and patient enrichment were also positively associated with successful marketing approval. Although similar designations and priority review systems for orphan drugs have been enacted, economic incentives and regulatory conditions provided by the systems seem to be different between the 2 countries, which may lead to varied performance in orphan designation and approval. We need to pay close attention to the impact of industrial global development strategies when comparing the outcomes and performance of different orphan drug promotion systems." @default.
- W2965972649 created "2019-08-13" @default.
- W2965972649 creator A5049496498 @default.
- W2965972649 creator A5076998922 @default.
- W2965972649 creator A5091099191 @default.
- W2965972649 date "2019-07-31" @default.
- W2965972649 modified "2023-10-16" @default.
- W2965972649 title "Survey of Japanese Orphan Drug Program: Factors Related to Successful Marketing Approval" @default.
- W2965972649 cites W1966768512 @default.
- W2965972649 cites W1978219245 @default.
- W2965972649 cites W1981858341 @default.
- W2965972649 cites W1983965561 @default.
- W2965972649 cites W1986881091 @default.
- W2965972649 cites W2007422794 @default.
- W2965972649 cites W2030234436 @default.
- W2965972649 cites W2036132972 @default.
- W2965972649 cites W2054519060 @default.
- W2965972649 cites W2079205051 @default.
- W2965972649 cites W2103044501 @default.
- W2965972649 cites W2119829512 @default.
- W2965972649 cites W2125416781 @default.
- W2965972649 cites W2171772467 @default.
- W2965972649 cites W2291797353 @default.
- W2965972649 cites W2754251620 @default.
- W2965972649 cites W2766543377 @default.
- W2965972649 cites W2810408942 @default.
- W2965972649 cites W2901313771 @default.
- W2965972649 cites W3122626150 @default.
- W2965972649 doi "https://doi.org/10.1002/jcph.1501" @default.
- W2965972649 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/6972571" @default.
- W2965972649 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/31364772" @default.
- W2965972649 hasPublicationYear "2019" @default.
- W2965972649 type Work @default.
- W2965972649 sameAs 2965972649 @default.
- W2965972649 citedByCount "3" @default.
- W2965972649 countsByYear W29659726492021 @default.
- W2965972649 countsByYear W29659726492022 @default.
- W2965972649 countsByYear W29659726492023 @default.
- W2965972649 crossrefType "journal-article" @default.
- W2965972649 hasAuthorship W2965972649A5049496498 @default.
- W2965972649 hasAuthorship W2965972649A5076998922 @default.
- W2965972649 hasAuthorship W2965972649A5091099191 @default.
- W2965972649 hasBestOaLocation W29659726491 @default.
- W2965972649 hasConcept C100001284 @default.
- W2965972649 hasConcept C144133560 @default.
- W2965972649 hasConcept C150903083 @default.
- W2965972649 hasConcept C162324750 @default.
- W2965972649 hasConcept C162853370 @default.
- W2965972649 hasConcept C175444787 @default.
- W2965972649 hasConcept C17744445 @default.
- W2965972649 hasConcept C199539241 @default.
- W2965972649 hasConcept C2780035454 @default.
- W2965972649 hasConcept C29122968 @default.
- W2965972649 hasConcept C2992293740 @default.
- W2965972649 hasConcept C60644358 @default.
- W2965972649 hasConcept C64903051 @default.
- W2965972649 hasConcept C71924100 @default.
- W2965972649 hasConcept C75480439 @default.
- W2965972649 hasConcept C86803240 @default.
- W2965972649 hasConcept C94625758 @default.
- W2965972649 hasConcept C98147612 @default.
- W2965972649 hasConcept C98274493 @default.
- W2965972649 hasConceptScore W2965972649C100001284 @default.
- W2965972649 hasConceptScore W2965972649C144133560 @default.
- W2965972649 hasConceptScore W2965972649C150903083 @default.
- W2965972649 hasConceptScore W2965972649C162324750 @default.
- W2965972649 hasConceptScore W2965972649C162853370 @default.
- W2965972649 hasConceptScore W2965972649C175444787 @default.
- W2965972649 hasConceptScore W2965972649C17744445 @default.
- W2965972649 hasConceptScore W2965972649C199539241 @default.
- W2965972649 hasConceptScore W2965972649C2780035454 @default.
- W2965972649 hasConceptScore W2965972649C29122968 @default.
- W2965972649 hasConceptScore W2965972649C2992293740 @default.
- W2965972649 hasConceptScore W2965972649C60644358 @default.
- W2965972649 hasConceptScore W2965972649C64903051 @default.
- W2965972649 hasConceptScore W2965972649C71924100 @default.
- W2965972649 hasConceptScore W2965972649C75480439 @default.
- W2965972649 hasConceptScore W2965972649C86803240 @default.
- W2965972649 hasConceptScore W2965972649C94625758 @default.
- W2965972649 hasConceptScore W2965972649C98147612 @default.
- W2965972649 hasConceptScore W2965972649C98274493 @default.
- W2965972649 hasFunder F4320320912 @default.
- W2965972649 hasIssue "1" @default.
- W2965972649 hasLocation W29659726491 @default.
- W2965972649 hasLocation W29659726492 @default.
- W2965972649 hasLocation W29659726493 @default.
- W2965972649 hasOpenAccess W2965972649 @default.
- W2965972649 hasPrimaryLocation W29659726491 @default.
- W2965972649 hasRelatedWork W1983692650 @default.
- W2965972649 hasRelatedWork W2045007867 @default.
- W2965972649 hasRelatedWork W2052581114 @default.
- W2965972649 hasRelatedWork W2249485035 @default.
- W2965972649 hasRelatedWork W2889213083 @default.
- W2965972649 hasRelatedWork W2898600723 @default.
- W2965972649 hasRelatedWork W2965972649 @default.
- W2965972649 hasRelatedWork W2980063373 @default.
- W2965972649 hasRelatedWork W3196397820 @default.
- W2965972649 hasRelatedWork W4293030616 @default.