Who is a 'healthy subject'?-consensus results on pivotal eligibility criteria for clinical trials (Q37699723)

22 August 2017

1 reference

19 September 2019

Who is a 'healthy subject'?-consensus results on pivotal eligibility criteria for clinical trials (English)

1 reference

biomedical investigative technique

22 August 2017

1 reference

19 September 2019

1 reference

3

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

Gerd Mikus

10

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

author name string

Kerstin Breithaupt-Groegler

1

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

Christoph Coch

2

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

Frank Donath

4

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

Katharina Erb-Zohar

5

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

Klaus Francke

6

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

Karin Goehler

7

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

Mario Iovino

8

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

Klaus Peter Kammerer

9

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

Jens Rengelshausen

11

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

Hildegard Sourgens

12

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

Reinhard Schinzel

13

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

Thomas Sudhop

14

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

Georg Wensing

15

1 reference

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9 June 2020

publication date

7 January 2017

1 reference

European Journal of Clinical Pharmacology

22 August 2017

1 April 2017

1 reference

19 September 2019

2 references

19 September 2019

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

volume

73

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

issue

4

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

page(s)

409-416

1 reference

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Creative Commons Attribution 4.0 International

9 June 2020

copyright license

1 reference

Morphological abnormalities in baseline ECGs in healthy normal volunteers participating in phase I studies.

19 September 2019

0 references

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5350217

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

23 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5350217

UGT1A polymorphisms in a Swedish cohort and a human diversity panel, and the relation to bilirubin plasma levels in males and females.

23 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5350217

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

23 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5350217

The placebo effect in healthy volunteers: influence of experimental conditions on physiological parameters during phase I studies

23 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5350217

Use of 24 h ambulatory ECG recordings in the assessment of new chemical entities in healthy volunteers

23 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5350217

Neuro-Bio-Behavioral Mechanisms of Placebo and Nocebo Responses: Implications for Clinical Trials and Clinical Practice

23 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5350217

Implications of the BIA-102474-101 study for review of first-into-human clinical trials

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5350217

Short-term and long-term intra-individual variations and critical differences of clinical chemical laboratory parameters.

23 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5350217

Diurnal variations in serum biochemical and haematological measurements

23 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5350217

Idioventricular rhythm: hypervagotonia associated with placebo

23 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5350217

Intra-individual variation in commonly analyzed serum constituents

23 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5350217

Reexamining transaminase elevation in Phase I clinical trials: the importance of baseline and change from baseline.

23 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5350217

Evaluation of asymptomatic microscopic hematuria in adults: the American Urological Association best practice policy--part II: patient evaluation, cytology, voided markers, imaging, cystoscopy, nephrology evaluation, and follow-up

1 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5350217

Placebo-associated blood pressure response and adverse effects in the treatment of hypertension: observations from a Department of Veterans Affairs Cooperative Study

1 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5350217

Baseline and new-onset morphologic ECG abnormalities in healthy volunteers in phase I studies receiving placebo: changes over a 6-week follow-up period

1 September 2018

1 reference

12 December 2020

Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products (EMEA/CHMP/SWP/28367/07 Rev. 1.

1 reference

12 December 2020

Research on healthy volunteers. A report of the Royal College of Physicians

1 reference

12 December 2020

Pronounced increase in serum creatinine concentration after eating cooked meat

1 reference

12 December 2020

[Critical value of bilirubin in the selection of healthy volunteers in for phase I]

1 reference

12 December 2020

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

1 reference

12 December 2020

10.1007/S00228-016-2189-8

Identifiers

DOI

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:28064353%20AND%20SRC:MED&resulttype=core&format=json

9 June 2020

PubMed publication ID

28064353

1 reference