(Q49937107)

English

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.

scientific article published on 16 February 2018

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scholarly article

1 reference

Europe PubMed Central

PubMed publication ID

23 February 2018

http://europepmc.org/abstract/MED/29451320

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. (English)

1 reference

Europe PubMed Central

PubMed publication ID

23 February 2018

http://europepmc.org/abstract/MED/29451320

Joop van Gerven

1

1 reference

Europe PubMed Central

PMC publication ID

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:29451320%20AND%20SRC:MED&resulttype=core&format=json

3 June 2020

2

1 reference

Europe PubMed Central

PMC publication ID

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:29451320%20AND%20SRC:MED&resulttype=core&format=json

3 June 2020

author name string

Joop van Gerven

1

1 reference

Europe PubMed Central

PubMed publication ID

23 February 2018

http://europepmc.org/abstract/MED/29451320

Milton Bonelli

2

1 reference

Europe PubMed Central

PubMed publication ID

23 February 2018

http://europepmc.org/abstract/MED/29451320

language of work or name

0 references

publication date

16 February 2018

1 reference

Europe PubMed Central

PubMed publication ID

23 February 2018

http://europepmc.org/abstract/MED/29451320

British Journal of Clinical Pharmacology

1 reference

Europe PubMed Central

PMC publication ID

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:29451320%20AND%20SRC:MED&resulttype=core&format=json

3 June 2020

84

1 reference

Europe PubMed Central

PMC publication ID

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:29451320%20AND%20SRC:MED&resulttype=core&format=json

3 June 2020

7

1 reference

Europe PubMed Central

PMC publication ID

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:29451320%20AND%20SRC:MED&resulttype=core&format=json

3 June 2020

1401-1409

1 reference

Europe PubMed Central

PMC publication ID

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:29451320%20AND%20SRC:MED&resulttype=core&format=json

3 June 2020

Analysis of integrated clinical trial protocols in early phases of medicinal product development

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

Activity-based protein profiling reveals off-target proteins of the FAAH inhibitor BIA 10-2474.

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

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

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

Open letter on access to the BIA 10-2474 clinical trial data

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

Acute Neurologic Disorder from an Inhibitor of Fatty Acid Amide Hydrolase

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

How to define reference intervals to rule in healthy individuals for clinical trials?

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

Seamless Oncology-Drug Development.

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

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

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

The return of the prodigal son and the extraordinary development route of antibody TGN1412 - lessons for drug development and clinical pharmacology

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

The use of biomarkers in human pharmacology (Phase I) studies

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

Effective visualization of integrated knowledge and data to enable informed decisions in drug development and translational medicine

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

Normal resting electrocardiographic variants in young athletes

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

The TeGenero incident and the Duff Report conclusions: a series of unfortunate events or an avoidable event?

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

Fatty acid amide hydrolase inhibitors display broad selectivity and inhibit multiple carboxylesterases as off-targets

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

Establishing risk of human experimentation with drugs: lessons from TGN1412.

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

International Conference on Harmonisation; guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; availability. Notice.

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=6005602

26 August 2018

Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival

1 reference

https://pubmed.ncbi.nlm.nih.gov/29451320

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

First-in-Human Clinical Trials — What We Can Learn from Tragic Failures

1 reference

https://pubmed.ncbi.nlm.nih.gov/29451320

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Identifiers

10.1111/BCP.13550

1 reference

Europe PubMed Central

PMC publication ID

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:29451320%20AND%20SRC:MED&resulttype=core&format=json

3 June 2020

PMC publication ID

1 reference

Europe PubMed Central

PMC publication ID

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:29451320%20AND%20SRC:MED&resulttype=core&format=json

3 June 2020

PubMed publication ID

1 reference

Europe PubMed Central

PMC publication ID

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:29451320%20AND%20SRC:MED&resulttype=core&format=json

3 June 2020

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