Paediatric Inflammatory Bowel Disease

Paediatric Inflammatory Bowel Disease: : A Multi-Stakeholder Perspective to Improve Development of Drugs for Children and Adolescents  Background and Aims: Despite recent approvals for new drugs to treat adults with Crohn’s disease or ulcerative colitis, there are only two ap[1]proved advanced treatment options [infliximab and adalimumab] for children with inflammatory bowel disease [IBD]. There are…

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Paediatric pharmacovigilance

c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A c4c expert group white paper by Aurich et al British Journal of Clinical Pharmacology – Wiley Online Library Children frequently respond differently to therapies compared to adults. Differences also exist between Paediatric age groups for pharmacokinetics and pharmacodynamics in both…

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Clinical Data Modelling

How Can a Clinical Data Modelling Tool Be Used to Represent Data Items of Relevance to Paediatric Clinical Trials? Learning from the Conect4children (c4c) Consortium The c4c have published a new article on the Direcht clinical data modelling tool in Applied Sciences.  “c4c is piloting the Direcht clinical data modelling tool to model their Cross Cutting…

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Health Technology Assessment of Paediatric Medicines

c4c have published ‘Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the conect4children project” in British Journal of Clinical Pharmacology.   “The medicine development process is complex and requires time and effort to ensure safety, efficacy and quality. In paediatrics, this process is even more challenging, as it involves a subgroup of…

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