(Q36835528)

16 August 2017

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title

Pharmacometrics at FDA: evolution and impact on decisions (English)

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16 August 2017

Powell JR

1

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16 August 2017

Gobburu JV

series ordinal

2

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16 August 2017

language of work or name

English

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publication date

30 May 2007

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Clinical Pharmacology & Therapeutics

16 August 2017

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16 August 2017

82

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16 August 2017

97-102

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16 August 2017

1

1 reference

https://scigraph.springernature.com/pub.10.1038/sj.clpt.6100234

16 August 2017

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cites work

Learning versus confirming in clinical drug development

1 reference

https://api.crossref.org/works/10.1038%2FSJ.CLPT.6100234

7 January 2021

Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development

1 reference

https://api.crossref.org/works/10.1038%2FSJ.CLPT.6100234

7 January 2021

A novel strategy for physiologically based predictions of human pharmacokinetics

1 reference

https://api.crossref.org/works/10.1038%2FSJ.CLPT.6100234

7 January 2021

Pharmacokinetic/pharmacodynamic modeling in drug development

1 reference

https://api.crossref.org/works/10.1038%2FSJ.CLPT.6100234

7 January 2021

Utilisation of pharmacokinetic-pharmacodynamic modelling and simulation in regulatory decision-making

1 reference

https://api.crossref.org/works/10.1038%2FSJ.CLPT.6100234

7 January 2021

Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval

1 reference

https://api.crossref.org/works/10.1038%2FSJ.CLPT.6100234

7 January 2021

Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications

1 reference

https://api.crossref.org/works/10.1038%2FSJ.CLPT.6100234

7 January 2021

Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006.

1 reference

https://api.crossref.org/works/10.1038%2FSJ.CLPT.6100234

7 January 2021

Peer-reviewed publication of clinical trials completed for pediatric exclusivity

1 reference

https://api.crossref.org/works/10.1038%2FSJ.CLPT.6100234

7 January 2021

Identifiers

DOI

10.1038/SJ.CLPT.6100234

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Dimensions Publication ID

16 August 2017

0 references

1 reference