(Q63865788)

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

16 February 2020

title

Risk management plans as a tool for proactive pharmacovigilance: a cohort study of newly approved drugs in Europe (English)

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

16 February 2020

2

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

16 February 2020

Toine Egberts

6

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

16 February 2020

Marie Louise De Bruin

8

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

16 February 2020

author name string

N S Vermeer

1

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

16 February 2020

S M J M Straus

3

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

16 February 2020

A K Mantel-Teeuwisse

4

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

16 February 2020

P R Arlett

5

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

16 February 2020

H G M Leufkens

7

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

16 February 2020

language of work or name

English

0 references

publication date

15 September 2014

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

Clinical Pharmacology & Therapeutics

16 February 2020

published in

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

16 February 2020

volume

96

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

16 February 2020

issue

6

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

16 February 2020

page(s)

723-731

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

European perspective on risk management and drug safety

16 February 2020

cites work

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

The safety of newly approved medicines: do recent market removals mean there is a problem?

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

External validity of randomised controlled trials: "to whom do the results of this trial apply?".

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Number of patients studied prior to approval of new medicines: a database analysis

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

COX-2 inhibitors--lessons in drug safety

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Evaluating drug effects in the post-Vioxx world: there must be a better way

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Biopharmaceutical benchmarks 2010

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

The biotechnology innovation machine: a source of intelligent biopharmaceuticals for the pharma industry--mapping biotechnology's success

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Traceability of Biopharmaceuticals in Spontaneous Reporting Systems: A Cross-Sectional Study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance Databases

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Evaluation of post-authorization safety studies in the first cohort of EU Risk Management Plans at time of regulatory approval.

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Risk Management Plans: are they a tool for improving drug safety?

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Risk minimization activities of centrally authorized products in the EU: a descriptive study

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Postmarketing surveillance--lack of vigilance, lack of trust.

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

The risks of risk aversion in drug regulation

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Does diabetes therapy influence the risk of cancer?

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Principles of signal detection in pharmacovigilance

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

New approaches to drug safety: a pharmacovigilance tool kit.

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

A critical review of methods to evaluate the impact of FDA regulatory actions.

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Efficient drug approval and monitoring must rely on sound regulatory science

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

From molecule to market access: drug regulatory science as an upcoming discipline

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Healthy animals and animal models of human disease(s) in safety assessment of human pharmaceuticals, including therapeutic antibodies

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Bioequivalence and the immunogenicity of biopharmaceuticals

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Differences between post-authorization adverse drug reactions of biopharmaceuticals and small molecules

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Safety learning from drugs of the same class: room for improvement.

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2014.184

7 January 2021

Identifiers

DOI

10.1038/CLPT.2014.184

1 reference

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:25222619%20AND%20SRC:MED&resulttype=core&format=json

16 February 2020

1 reference