Results 81 to 90 of about 141,698 (289)

How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU

British Journal of Clinical Pharmacology, EarlyView.
The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley   +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

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

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

ATC bridge, 2016

, 2016
Advanced Technologies Centre (ATC) bridge, Hawthorn Campus, looking up. Photograph appeared in the Media Centre Release 'Swinburne continues its commitment to support refugees' on 22 June ...
Swinburne University of Technology
core   +1 more source

Practicality of Acute and Transitional Care and its consequences in the era of SwissDRG: a focus group study

BMC Health Services Research, 2019
Background Switzerland recently introduced Acute and Transitional Care (ATC) as a new financing option and a preventive measure to mitigate potential side effects of Swiss Diagnosis Related Group (SwissDRG).
Tenzin Wangmo, Yvonne Padrutt, Insa Koné, Thomas Gächter, Bernice S. Elger, Agnes Leu   +5 more
doaj   +1 more source

Impurity concentration in the ATC [PDF]

, 1973
The impurity level in the ATC before compression was investigated by spectroscopic measurements. The first experimental results concerning the concentrations and the influence of impurities on some discharge characteristics are given. (auth)
openaire   +2 more sources

Case‐malformed signal detection and prioritisation using EUROmediCAT data for pharmacovigilance in pregnancy

British Journal of Clinical Pharmacology, EarlyView.
Aim Many women take medications during pregnancy. However, the risk to the fetus from most medications is uncertain. Congenital anomalies are one of the leading causes of infant death and contribute to long‐term disability. Signal detection methods can be used to systematically identify possible medication–anomaly associations that require further ...
Hannah Johnson, Helen Dolk, Maria Loane, Christine Damase‐Michel, Joanne Given, Hedvig Nordeng, Jorieke E. H. Bergman, Iain Carey, Elly Den Hond, Ester Garne, Florence Rouget, Lea Bruneau, Isabelle Monier, Anke Rissmann, Mary O'Mahony, Miriam Gatt, Renée Lutke, Joanna Sichitiu, Elisa Ballardini, Alessio Coi, Clara Cavero Carbonell, David Tucker, Joan Morris   +22 more
wiley   +1 more source

ATC steps at night, 2011

, 2011
Advanced Technologies Centre (ATC) grass steps at night, Hawthorn Campus, 10 June ...
Andrew Sampson
core   +1 more source

Effective Lenvatinib Treatment Complicated with Secondary Tracheocutaneous Fistula in Patients with Advanced Anaplastic Thyroid Carcinoma

Reports, 2019
Anaplastic thyroid carcinoma (ATC) is a fatal disease with a poor prognosis. Lenvatinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) which is approved in Japan for the treatment of ATC.
Wen-Chi Wu, Jiun-I Lai, Jui-Yu Chen, Chun-Yu Liu   +3 more
doaj   +1 more source