Results 71 to 80 of about 15,630 (215)

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

Introduction of biosimilar insulins in Europe.

, 2017
Regulatory approval of the first biosimilar insulin in Europe, LY2963016 insulin glargine (Abasaglar® ), in 2014 expanded the treatment options available to people with diabetes. As biosimilar insulin products come to market, it is important to recognize
J. Kiljanski (7721330), D. Dahl (7721324), Melanie Davies (545715), C. Mathieu (634100), T. Heise (7721327)   +4 more
core   +6 more sources

Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany

Pharmaceuticals, 2020
Drug budget and prescription control measures are implemented regionally in Germany, meaning that the uptake of pharmaceuticals, including biosimilars, can vary by region.
Evelien Moorkens, Teresa Barcina Lacosta, Arnold G. Vulto, Martin Schulz, Gabriele Gradl, Salka Enners, Gisbert Selke, Isabelle Huys, Steven Simoens   +8 more
doaj   +1 more source

Charge Variants of an Avastin Biosimilar Isolation, Characterization, In Vitro Properties and Pharmacokinetics in Rat. [PDF]

PLoS ONE, 2016
The similarity between a proposed biosimilar product and the reference product can be affected by many factors. This study is designed to examine whether any subtle difference in the distribution of the charge variants of an Avastin biosimilar can affect
Yan-Yan Zhao, Ning Wang, Wan-Hui Liu, Wen-Jie Tao, Li-Li Liu, Zhen-Duo Shen   +5 more
doaj   +1 more source

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source

Practical Issues Concerning the Approval and Use of Biosimilar Drugs for the Treatment of Multiple Sclerosis in Latin America

Neurology and Therapy, 2019
The use of biosimilar drugs for multiple sclerosis (MS) has become widespread in Latin America, with the goal of reducing costs of treatments, promoting the sustainability of healthcare systems, and improving patient access to these therapies.
Judith Steinberg, Yara D. Fragoso, Juan Carlos Duran Quiroz, Juan Raul García, Caroline Guerra, Virginia Rodriguez, Claudia Carcamo Rodriguez, Ethel Ciampi, Edgar Correa-Diaz, Miguel Macías, Nelson Novarro, Darwin Vizcarra, Carlos Oehninger Gatti, Geraldine Orozco, Adriana Carrá   +14 more
doaj   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Capacity building in medicines development and regulation in Africa—Overview on recent progress

British Journal of Clinical Pharmacology, EarlyView.
Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke, Emile Malan, Michael Reid, Patrick Bouic, Haylene Nell, Goonaseelan Pillai, Catriona Waitt, Bernd Rosenkranz   +7 more
wiley   +1 more source

Implementation and use of risk minimization control tools in the EU: A multistakeholder survey

British Journal of Clinical Pharmacology, EarlyView.
Aims This study characterized stakeholders' experiences with national implementation of risk minimization control tools (RMCTs), such as healthcare professional qualification, healthcare facility accreditation and medical intervention prior to treatment initiation, for eight medicinal products across eight European Union countries. Methods We conducted
Sharon C. M. Essink, Iris R. Joosse, Maximilian Salcher‐Konrad, Melanie Walter, Elena Deligianni, Dimitra Tsioumela, Christos Kontogiorgis, Elita Poplavska, Iluta Žīgure, Christina E. Hoeve, Teresa Leonardo Alves, Ella D. van Vliet, Renato Ferreira‐da‐Silva, Ana Kodrič, Mitja Kos, Juan Erviti, Marta Gutiérrez‐Valencia, Luis Carlos Saiz, Sofia Kälvemark Sporrong, Emelie Karlsson, Christine Leopold, Marie L. De Bruin   +21 more
wiley   +1 more source