Results 31 to 40 of about 27,665 (215)

Preregistration of high‐quality protocols in pharmacoepidemiology research

JCPP Advances
Pharmacoepidemiology studies are an important complement to Randomized Clinical trials, but such studies face several challenges, such as confounding and selective reporting.
Henrik Larsson, Zhang Chang, Kenneth K. C. Man   +2 more
doaj   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

British Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis, Christine Leopold, Joyce M. Hoek, Raymond M. Schiffelers, Marie L. De Bruin   +4 more
wiley   +1 more source

Study designs in paediatric pharmacoepidemiology [PDF]

, 2010
Purpose Few data on the efficacy and safety of drugs in children are available as in the past, these children were not included in randomized controlled trials (RCTs). Data on the efficacy and safety of drugs in children are extrapolated from adults. The
Sturkenboom, Miriam, Miriam Sturkenboom, Katia Verhamme, Verhamme, Katia, Sturkenboom, MCJM, Verhamme, Katia; id_orcid   +5 more
core   +1 more source

Evaluating the (comparative) safety profile of the novel oral polio vaccine type 2 using individual case safety reports in VigiBase

British Journal of Clinical Pharmacology, EarlyView.
Aim Novel oral polio vaccine type 2 (nOPV2) was used under the WHO emergency use listing for circulating vaccine‐derived polio virus (cVDPV) outbreaks from 2021 to 2023. We assessed nOPV2 adverse events following immunization (AEFIs) and compared its safety profile to other vaccines using VigiBase.
Comfort Kunak Ogar, Malede Mequanent Sisay, Leonardo Roque‐Pereira, Christine Leopold, Patrick C. Souverein, Aukje K. Mantel‐Teeuwisse, Marie L. De Bruin   +6 more
wiley   +1 more source

Pharmacoepidemiology.

, 2012
Current concerns over the safety of medicines once they have been marketed mean that pharmacoepidemiology is of increasing importance. There are three main areas in which further research is needed.
Evans, Stephen JW
core   +1 more source

Pharmacoepidemiological approaches for population-based hypothesis testing [PDF]

, 2018
Pharmacoepidemiology aims to study the use and both the adverse and beneficial effects of drugs and vaccines in the population after market authorization. The efficacy of drugs is assessed in experimental studies before a drug is allowed on the market in
Klungel, Olaf H., Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Olaf H. Klungel   +3 more
core   +2 more sources

Characteristics and temporal trends of EU teratological safety signals and information dissemination to healthcare professionals in the Netherlands—A contribution of the ConcePTION project

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Although regulatory responses to safety signals have been studied, pregnancy‐specific data and their dissemination to medical professionals remain unclear. This study examined the characteristics and temporal trends of teratological safety signals prompting the European Medicines Agency to implement risk minimization measures.
Yrea R. J. van Rijt‐Weetink, Rosanne E. Huisman, Jan‐Peter van Wieringen, H. J. M. J. (Ineke) Crijns, Florence P. A. M. van Hunsel, Anneke L. M. Passier, Sander Borgsteede, A. C. G. (Toine) Egberts, Laura M. Yates, Eugène P. van Puijenbroek   +9 more
wiley   +1 more source

Pharmacoepidemiology

مجله دانشکده پزشکی اصفهان, 2016
Pharmacoepidemiology
Ali Mohammad Sabzghabaee
doaj  

Pharmacokinetics and pharmacoepidemiology

, 1994
Pharmacokinetic methodology should be included in pharmacoepidemiology and postmarketing ...
J Zuidema, H G M Leufkens
core   +1 more source