Matches in SemOpenAlex for { <https://semopenalex.org/work/W2912166602> ?p ?o ?g. }
Showing items 1 to 79 of
79
with 100 items per page.
- W2912166602 endingPage "112" @default.
- W2912166602 startingPage "82" @default.
- W2912166602 abstract "In this chapter, the objectives of exploratory development and the planning of studies to meet those objectives are discussed. The preclinical requirements for administration of a new molecular entity to humans are presented briefly. Use of healthy volunteers in exploratory studies is described. There are a variety of designs for the first-in-human study each with its own advantages and disadvantages but risk should always be minimised. Exploratory studies should provide information about pharmacokinetics and pharmacodynamic activity with which to evaluate the relationship between dose, concentration and both desired and undesired effects, thereby providing a preliminary assessment of benefit–risk. Subsequent studies in healthy volunteers and patients using surrogate or clinical endpoints should provide the essential information with which to make go/no-go decisions." @default.
- W2912166602 created "2019-02-21" @default.
- W2912166602 creator A5012888806 @default.
- W2912166602 creator A5014917654 @default.
- W2912166602 creator A5015868104 @default.
- W2912166602 creator A5080765883 @default.
- W2912166602 date "2013-04-18" @default.
- W2912166602 modified "2023-10-14" @default.
- W2912166602 title "Exploratory Development" @default.
- W2912166602 cites W1975871632 @default.
- W2912166602 cites W1993527529 @default.
- W2912166602 cites W2002374666 @default.
- W2912166602 cites W2034194552 @default.
- W2912166602 cites W2042446689 @default.
- W2912166602 cites W2063732330 @default.
- W2912166602 cites W2070424320 @default.
- W2912166602 cites W2082515490 @default.
- W2912166602 cites W2087684961 @default.
- W2912166602 cites W2095345961 @default.
- W2912166602 cites W2121349080 @default.
- W2912166602 doi "https://doi.org/10.1002/9781118532331.ch4" @default.
- W2912166602 hasPublicationYear "2013" @default.
- W2912166602 type Work @default.
- W2912166602 sameAs 2912166602 @default.
- W2912166602 citedByCount "0" @default.
- W2912166602 crossrefType "other" @default.
- W2912166602 hasAuthorship W2912166602A5012888806 @default.
- W2912166602 hasAuthorship W2912166602A5014917654 @default.
- W2912166602 hasAuthorship W2912166602A5015868104 @default.
- W2912166602 hasAuthorship W2912166602A5080765883 @default.
- W2912166602 hasConcept C112930515 @default.
- W2912166602 hasConcept C127413603 @default.
- W2912166602 hasConcept C136197465 @default.
- W2912166602 hasConcept C144024400 @default.
- W2912166602 hasConcept C144133560 @default.
- W2912166602 hasConcept C154945302 @default.
- W2912166602 hasConcept C19165224 @default.
- W2912166602 hasConcept C195094911 @default.
- W2912166602 hasConcept C2522767166 @default.
- W2912166602 hasConcept C3018260909 @default.
- W2912166602 hasConcept C41008148 @default.
- W2912166602 hasConcept C539667460 @default.
- W2912166602 hasConcept C71924100 @default.
- W2912166602 hasConcept C85973986 @default.
- W2912166602 hasConcept C98274493 @default.
- W2912166602 hasConceptScore W2912166602C112930515 @default.
- W2912166602 hasConceptScore W2912166602C127413603 @default.
- W2912166602 hasConceptScore W2912166602C136197465 @default.
- W2912166602 hasConceptScore W2912166602C144024400 @default.
- W2912166602 hasConceptScore W2912166602C144133560 @default.
- W2912166602 hasConceptScore W2912166602C154945302 @default.
- W2912166602 hasConceptScore W2912166602C19165224 @default.
- W2912166602 hasConceptScore W2912166602C195094911 @default.
- W2912166602 hasConceptScore W2912166602C2522767166 @default.
- W2912166602 hasConceptScore W2912166602C3018260909 @default.
- W2912166602 hasConceptScore W2912166602C41008148 @default.
- W2912166602 hasConceptScore W2912166602C539667460 @default.
- W2912166602 hasConceptScore W2912166602C71924100 @default.
- W2912166602 hasConceptScore W2912166602C85973986 @default.
- W2912166602 hasConceptScore W2912166602C98274493 @default.
- W2912166602 hasLocation W29121666021 @default.
- W2912166602 hasOpenAccess W2912166602 @default.
- W2912166602 hasPrimaryLocation W29121666021 @default.
- W2912166602 hasRelatedWork W1835203835 @default.
- W2912166602 hasRelatedWork W1964754797 @default.
- W2912166602 hasRelatedWork W2117690866 @default.
- W2912166602 hasRelatedWork W2163533617 @default.
- W2912166602 hasRelatedWork W2170254786 @default.
- W2912166602 hasRelatedWork W2375949218 @default.
- W2912166602 hasRelatedWork W2748952813 @default.
- W2912166602 hasRelatedWork W2899084033 @default.
- W2912166602 hasRelatedWork W2946675872 @default.
- W2912166602 hasRelatedWork W3116028294 @default.
- W2912166602 isParatext "false" @default.
- W2912166602 isRetracted "false" @default.
- W2912166602 magId "2912166602" @default.
- W2912166602 workType "other" @default.