(Q41451789)

30 September 2017

title

Catalyzing the Critical Path Initiative: FDA's progress in drug development activities (English)

1 reference

30 September 2017

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A Parekh

1

1 reference

30 September 2017

S Buckman-Garner

2

1 reference

30 September 2017

S McCune

3

1 reference

30 September 2017

R ONeill

4

1 reference

30 September 2017

M Geanacopoulos

5

1 reference

30 September 2017

S Amur

6

1 reference

30 September 2017

C Clingman

7

1 reference

30 September 2017

R Barratt

8

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30 September 2017

M Rocca

9

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30 September 2017

I Hills

10

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30 September 2017

J Woodcock

11

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30 September 2017

language of work or name

English

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publication date

28 January 2015

1 reference

Clinical Pharmacology & Therapeutics

30 September 2017

published in

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30 September 2017

volume

97

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30 September 2017

issue

3

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30 September 2017

page(s)

221-233

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The international serious adverse events consortium.

30 September 2017

cites work

1 reference

Tablet Splitting of a Narrow Therapeutic Index Drug: A Case with Levothyroxine Sodium

21 January 2018

1 reference

Misclassification and discordance of measured blood pressure from patient's true blood pressure in current clinical practice: a clinical trial simulation case study

21 January 2018

1 reference

A systematic comparison of cockcroft-gault and modification of diet in renal disease equations for classification of kidney dysfunction and dosage adjustment.

21 January 2018

1 reference

Application of physiologically based pharmacokinetic modeling to predict acetaminophen metabolism and pharmacokinetics in children

21 January 2018

1 reference

The UCSF-FDA TransPortal: a public drug transporter database

21 January 2018

1 reference

Use of partial area under the curve metrics to assess bioequivalence of methylphenidate multiphasic modified release formulations

21 January 2018

1 reference

Performance of pharmacovigilance signal-detection algorithms for the FDA adverse event reporting system

21 January 2018

1 reference

Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.

21 January 2018

1 reference

The utility of modeling and simulation in drug development and regulatory review

21 January 2018

1 reference

A modeling and simulation approach to characterize methadone QT prolongation using pooled data from five clinical trials in MMT patients

21 January 2018

1 reference

Rechanneling the cardiac proarrhythmia safety paradigm: a meeting report from the Cardiac Safety Research Consortium.

21 January 2018

1 reference

Rationale and design of the dual antiplatelet therapy study, a prospective, multicenter, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy in subjects undergoing percutaneous co

21 January 2018

1 reference

Precompetitive research: a new prescription for drug development?

21 January 2018

1 reference

inferred from DOI database lookup

7 January 2021

based on heuristic

Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact

1 reference

inferred from DOI database lookup

7 January 2021

based on heuristic

Identifiers

DOI

10.1002/CPT.42

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30 September 2017

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