Literature DB >> 30051230

Is pharmacovigilance of biologicals cost-effective?

Barbara Claus1.   

Abstract

Pharmacovigilance is an essential part of the post-marketing surveillance of new biologicals. It not only requires a substantial investment of the marketing authorization holder but also of the clinical field to provide accurate safety information. Hence, does pharmacovigilance delivers value for money? This important question needs to be discussed in the light of regulatory requirements, value and cost.

Keywords:  Biologicals; Biosimilars; Cost-effectiveness; Pharmacovigilance

Mesh：

Substances：

Year:  2018        PMID： 30051230     DOI： 10.1007/s11096-018-0695-8

Source DB:  PubMed          Journal:  Int J Clin Pharm


  8 in total

1.  The cost-effectiveness of periodic safety update reports for biologicals in Europe.

Authors:  J C Bouvy; H C Ebbers; H Schellekens; M A Koopmanschap
Journal:  Clin Pharmacol Ther       Date:  2013-01-24       Impact factor: 6.875

2.  Benefit-risk reassessment of medicines: a retrospective analysis of all safety-related referral procedures in Europe during 2001-2012.

Authors:  Jacoline C Bouvy; Lotte Huinink; Marie L De Bruin
Journal:  Pharmacoepidemiol Drug Saf       Date:  2016-05-04       Impact factor: 2.890

3.  Mapping the safety profile of biologicals: a disproportionality analysis using the WHO adverse drug reaction database, VigiBase.

Authors:  Thijs J Giezen; Aukje K Mantel-Teeuwisse; Ronald H B Meyboom; Sabine M J M Straus; Hubert G M Leufkens; Toine C G Egberts
Journal:  Drug Saf       Date:  2010-10-01       Impact factor: 5.606

4.  A method for estimating the probability of adverse drug reactions.

Authors:  C A Naranjo; U Busto; E M Sellers; P Sandor; I Ruiz; E A Roberts; E Janecek; C Domecq; D J Greenblatt
Journal:  Clin Pharmacol Ther       Date:  1981-08       Impact factor: 6.875

5.  Development of a flowchart for risk assessment and allocation of preparation of monoclonal antibodies.

Authors:  Tiene Bauters; Johan Vandenbroucke
Journal:  J Oncol Pharm Pract       Date:  2017-12-03       Impact factor: 1.809

6.  Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

Authors:  Nicholas S Downing; Nilay D Shah; Jenerius A Aminawung; Alison M Pease; Jean-David Zeitoun; Harlan M Krumholz; Joseph S Ross
Journal:  JAMA       Date:  2017-05-09       Impact factor: 56.272

7.  Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports.

Authors:  Kevin Klein; Joep H G Scholl; Niels S Vermeer; André W Broekmans; Eugène P Van Puijenbroek; Marie L De Bruin; Pieter Stolk
Journal:  Drug Saf       Date:  2016-02       Impact factor: 5.606

Review 8.  Overcoming Barriers to the Market Access of Biosimilars in the European Union: The Case of Biosimilar Monoclonal Antibodies.

Authors:  Evelien Moorkens; Clara Jonker-Exler; Isabelle Huys; Paul Declerck; Steven Simoens; Arnold G Vulto
Journal:  Front Pharmacol       Date:  2016-06-29       Impact factor: 5.810
  8 in total
  2 in total

1.  Overview of this issue: pharmacovigilance, what is new?

Authors:  Linda Gore Martin; Yolande Hanssens; Vibhu Paudyal
Journal:  Int J Clin Pharm       Date:  2018-08

2.  Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions.

Authors:  Luis Correia Pinheiro; Thijs J Giezen; Elena Wolff-Holz; Martina Weise; Andrea Laslop; Ana Hidalgo-Simon
Journal:  Clin Pharmacol Ther       Date:  2021-09-26       Impact factor: 6.903
  2 in total

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