Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

A Segec; B Keller-Stanislawski; N S Vermeer; C Macchiarulo; S M Straus; A Hidalgo-Simon; M L De Bruin

doi:10.1002/cpt.199

Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

A Segec, B Keller-Stanislawski, N S Vermeer, C Macchiarulo, S M Straus, A Hidalgo-Simon, M L De Bruin

3 Citationer (Scopus)

Abstract

Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe use of medicines. Considering the need for consistent outcomes of regulatory decisions, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) used PML as an example to develop a systematic approach to labeling and risk minimization.

Originalsprog	Engelsk
Tidsskrift	Clinical Pharmacology and Therapeutics
Vol/bind	98
Udgave nummer	5
Sider (fra-til)	502-5
Antal sider	4
ISSN	0009-9236
DOI	https://doi.org/10.1002/cpt.199
Status	Udgivet - 1 nov. 2015
Udgivet eksternt	Ja

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10.1002/cpt.199

Citationsformater

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title = "Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy",

abstract = "Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe use of medicines. Considering the need for consistent outcomes of regulatory decisions, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) used PML as an example to develop a systematic approach to labeling and risk minimization.",

keywords = "Antibodies, Monoclonal, Humanized, Decision Making, Disease Management, Drug-Related Side Effects and Adverse Reactions, Humans, Leukoencephalopathy, Progressive Multifocal, Risk Assessment, Journal Article, Review",

author = "A Segec and B Keller-Stanislawski and Vermeer, {N S} and C Macchiarulo and Straus, {S M} and A Hidalgo-Simon and {De Bruin}, {M L}",

note = "{\textcopyright} 2015 American Society for Clinical Pharmacology and Therapeutics.",

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doi = "10.1002/cpt.199",

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T1 - Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

AU - Segec, A

AU - Keller-Stanislawski, B

AU - Vermeer, N S

AU - Macchiarulo, C

AU - Straus, S M

AU - Hidalgo-Simon, A

AU - De Bruin, M L

PY - 2015/11/1

Y1 - 2015/11/1

N2 - Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe use of medicines. Considering the need for consistent outcomes of regulatory decisions, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) used PML as an example to develop a systematic approach to labeling and risk minimization.

AB - Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe use of medicines. Considering the need for consistent outcomes of regulatory decisions, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) used PML as an example to develop a systematic approach to labeling and risk minimization.

KW - Antibodies, Monoclonal, Humanized

KW - Decision Making

KW - Disease Management

KW - Drug-Related Side Effects and Adverse Reactions

KW - Humans

KW - Leukoencephalopathy, Progressive Multifocal

KW - Risk Assessment

KW - Journal Article

KW - Review

U2 - 10.1002/cpt.199

DO - 10.1002/cpt.199

M3 - Journal article

C2 - 26250806

SN - 0009-9236

VL - 98

SP - 502

EP - 505

JO - Clinical Pharmacology and Therapeutics

JF - Clinical Pharmacology and Therapeutics

IS - 5

ER -

Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

Abstract

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