Matches in SemOpenAlex for { <https://semopenalex.org/work/W4385587097> ?p ?o ?g. }
Showing items 1 to 52 of
52
with 100 items per page.
- W4385587097 endingPage "469" @default.
- W4385587097 startingPage "465" @default.
- W4385587097 abstract "A sponsor of a new pharmaceutical must submit a new drug application (NDA) to obtain marketing approval from the US Food and Drug Administration (FDA). The NDA must contain substantial evidence to demonstrate the pharmaceutical's safety and effectiveness. This chapter will provide an overview of the regulatory background pertaining to NDAs, including the approval pathways and steps leading to submission, as well as a brief overview of FDA's NDA review process." @default.
- W4385587097 created "2023-08-05" @default.
- W4385587097 creator A5006350041 @default.
- W4385587097 creator A5026098129 @default.
- W4385587097 creator A5058181890 @default.
- W4385587097 date "2023-01-01" @default.
- W4385587097 modified "2023-10-16" @default.
- W4385587097 title "New drug application" @default.
- W4385587097 doi "https://doi.org/10.1016/b978-0-323-88423-5.00073-x" @default.
- W4385587097 hasPublicationYear "2023" @default.
- W4385587097 type Work @default.
- W4385587097 citedByCount "0" @default.
- W4385587097 crossrefType "book-chapter" @default.
- W4385587097 hasAuthorship W4385587097A5006350041 @default.
- W4385587097 hasAuthorship W4385587097A5026098129 @default.
- W4385587097 hasAuthorship W4385587097A5058181890 @default.
- W4385587097 hasConcept C112930515 @default.
- W4385587097 hasConcept C144133560 @default.
- W4385587097 hasConcept C2776876202 @default.
- W4385587097 hasConcept C2779535233 @default.
- W4385587097 hasConcept C2780035454 @default.
- W4385587097 hasConcept C2992293740 @default.
- W4385587097 hasConcept C3018890749 @default.
- W4385587097 hasConcept C71924100 @default.
- W4385587097 hasConcept C98274493 @default.
- W4385587097 hasConceptScore W4385587097C112930515 @default.
- W4385587097 hasConceptScore W4385587097C144133560 @default.
- W4385587097 hasConceptScore W4385587097C2776876202 @default.
- W4385587097 hasConceptScore W4385587097C2779535233 @default.
- W4385587097 hasConceptScore W4385587097C2780035454 @default.
- W4385587097 hasConceptScore W4385587097C2992293740 @default.
- W4385587097 hasConceptScore W4385587097C3018890749 @default.
- W4385587097 hasConceptScore W4385587097C71924100 @default.
- W4385587097 hasConceptScore W4385587097C98274493 @default.
- W4385587097 hasLocation W43855870971 @default.
- W4385587097 hasOpenAccess W4385587097 @default.
- W4385587097 hasPrimaryLocation W43855870971 @default.
- W4385587097 hasRelatedWork W1572265341 @default.
- W4385587097 hasRelatedWork W1972804040 @default.
- W4385587097 hasRelatedWork W2003507389 @default.
- W4385587097 hasRelatedWork W2016229109 @default.
- W4385587097 hasRelatedWork W2277445211 @default.
- W4385587097 hasRelatedWork W2979981175 @default.
- W4385587097 hasRelatedWork W3033028959 @default.
- W4385587097 hasRelatedWork W4254153383 @default.
- W4385587097 hasRelatedWork W4301195367 @default.
- W4385587097 hasRelatedWork W4301669357 @default.
- W4385587097 isParatext "false" @default.
- W4385587097 isRetracted "false" @default.
- W4385587097 workType "book-chapter" @default.