Pharmacokinetics/Pharmacodynamics and the stages of drug development: role of modeling and simulation (Q36341664)

13 August 2017

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title

Pharmacokinetics/Pharmacodynamics and the stages of drug development: role of modeling and simulation (English)

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13 August 2017

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Jenny Y Chien

1

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13 August 2017

Stuart Friedrich

2

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13 August 2017

Michael A Heathman

3

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13 August 2017

Dinesh P de Alwis

4

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13 August 2017

Vikram Sinha

5

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13 August 2017

language of work or name

English

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publication date

7 October 2005

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13 August 2017

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13 August 2017

7

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13 August 2017

3

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13 August 2017

E544-59

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

13 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751257

Use of prior information to stabilize a population data analysis

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751257

A population pharmacokinetic model for doxorubicin and doxorubicinol in the presence of a novel MDR modulator, zosuquidar trihydrochloride (LY335979).

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751257

Considerations in the design and development of transport inhibitors as adjuncts to drug therapy

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751257

Relation between QT and RR intervals is highly individual among healthy subjects: implications for heart rate correction of the QT interval

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751257

Simulation of clinical trials

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751257

Pharmacokinetic/pharmacodynamic modeling in drug development

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751257

The effect of quinidine and its metabolites on the electrocardiogram and systolic time intervals: concentration--effect relationships.

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751257

Learning versus confirming in clinical drug development

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751257

Prediction of the outcome of a phase 3 clinical trial of an antischizophrenic agent (quetiapine fumarate) by simulation with a population pharmacokinetic and pharmacodynamic model.

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751257

Population pharmacokinetic model for daunorubicin and daunorubicinol coadministered with zosuquidar.3HCl (LY335979).

29 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751257

Optimization of individual and population designs using Splus

22 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751257

Evaluating pharmacokinetic/pharmacodynamic models using the posterior predictive check

22 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751257

Optimal design of a population pharmacodynamic experiment for ivabradine

22 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751257

A dose-finding and pharmacokinetic study of reversal of multidrug resistance with SDZ PSC 833 in combination with doxorubicin in patients with solid tumors.

22 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751257

Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans

22 September 2018

1 reference

12 December 2020

Integration of pharmacokinetic and pharmacodynamic studies in the discovery, development, and review of protein therapeutic agents: a conference report

1 reference

12 December 2020

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

1 reference

12 December 2020

Experimental design and efficient parameter estimation in preclinical pharmacokinetic studies

1 reference

12 December 2020

Identifiers

DOI

10.1208/AAPSJ070355

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Dimensions Publication ID

13 August 2017

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13 August 2017

PubMed publication ID

16353932

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