(Q34381371)

English

A safety grading scale to support dose escalation and define stopping rules for healthy subject first-entry-into-man studies: some points to consider from the French Club Phase I working group

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scholarly article

1 reference

Europe PubMed Central

PubMed publication ID

1 August 2017

A safety grading scale to support dose escalation and define stopping rules for healthy subject first-entry-into-man studies: some points to consider from the French Club Phase I working group (English)

1 reference

Europe PubMed Central

PubMed publication ID

1 August 2017

author name string

Michel Sibille

1

1 reference

Europe PubMed Central

PubMed publication ID

1 August 2017

Alain Patat

2

1 reference

Europe PubMed Central

PubMed publication ID

1 August 2017

Henri Caplain

3

1 reference

Europe PubMed Central

PubMed publication ID

1 August 2017

Yves Donazzolo

4

1 reference

Europe PubMed Central

PubMed publication ID

1 August 2017

language of work or name

0 references

publication date

1 November 2010

1 reference

Europe PubMed Central

PubMed publication ID

1 August 2017

British Journal of Clinical Pharmacology

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Europe PubMed Central

PubMed publication ID

1 August 2017

70

1 reference

Europe PubMed Central

PubMed publication ID

1 August 2017

5

1 reference

Europe PubMed Central

PubMed publication ID

1 August 2017

736-748

1 reference

Europe PubMed Central

PubMed publication ID

1 August 2017

Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2997314

6 July 2018

After the London tragedy, is it still possible to consider Phase I is safe?

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2997314

6 July 2018

Guidelines on management (diagnosis and treatment) of syncope--update 2004.

1 reference

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Transaminase elevation on placebo during phase I trials: prevalence and significance

1 reference

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6 July 2018

Laboratory data in healthy volunteers: reference values, reference changes, screening and laboratory adverse event limits in Phase I clinical trials

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2997314

6 July 2018

Causality assessment of adverse reactions to drugs--I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries

1 reference

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6 July 2018

Reporting results of cancer treatment

1 reference

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6 July 2018

Criteria of drug-induced liver disorders. Report of an international consensus meeting

1 reference

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6 July 2018

The hypereosinophilic syndrome: analysis of fourteen cases with review of the literature

1 reference

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6 July 2018

'Hy's law,' the 'Rezulin Rule,' and other predictors of severe drug-induced hepatotoxicity: putting risk-benefit into perspective

1 reference

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27 October 2018

Case records of the Massachusetts General Hospital. Weekly clinicopathological exercises. Laboratory reference values.

1 reference

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27 October 2018

Supplemental guidance on testing for replication-competent retrovirus in retroviral vector-based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors

1 reference

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27 October 2018

Critical limits to define a lab adverse event during phase I studies: a study in 1134 subjects

1 reference

https://pubmed.ncbi.nlm.nih.gov/21039768

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects

1 reference

https://pubmed.ncbi.nlm.nih.gov/21039768

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Adverse events in phase-I studies: a report in 1015 healthy volunteers

1 reference

https://pubmed.ncbi.nlm.nih.gov/21039768

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Identifiers

10.1111/J.1365-2125.2010.03741.X

1 reference

Europe PubMed Central

PubMed publication ID

1 August 2017

PMC publication ID

1 reference

Europe PubMed Central

PubMed publication ID

1 August 2017

PubMed publication ID

1 reference

Europe PubMed Central

PubMed publication ID

1 August 2017

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