Literature DB >> 18454566

The new European regulation on pediatric medicines: regulatory perspective.

Daniel B Hawcutt, Rosalind L Smyth.   

Abstract

Mesh：

Year:  2008        PMID： 18454566     DOI： 10.2165/00148581-200810030-00002

Source DB:  PubMed          Journal:  Paediatr Drugs        ISSN： 1174-5878            Impact factor:   3.022


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  4 in total

Review 1.  The European Regulation on medicines for paediatric use.

Authors:  Julia Dunne
Journal:  Paediatr Respir Rev       Date:  2007-05-30       Impact factor: 2.726

Review 2.  The EU's new paediatric medicines legislation: serving children's needs?

Authors:  Govin Permanand; Elias Mossialos; Martin McKee
Journal:  Arch Dis Child       Date:  2007-09       Impact factor: 3.791

3.  Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children.

Authors:  S Conroy; I Choonara; P Impicciatore; A Mohn; H Arnell; A Rane; C Knoeppel; H Seyberth; C Pandolfini; M P Raffaelli; F Rocchi; M Bonati; G Jong; M de Hoog; J van den Anker
Journal:  BMJ       Date:  2000-01-08

4.  Therapeutic orphans, pediatric victims? The Best Pharmaceuticals for Child Act and existing pediatric human subject protection.

Authors:  Glenn Cohen
Journal:  Food Drug Law J       Date:  2003       Impact factor: 0.619
  4 in total
  4 in total

Review 1.  Two decades of off-label prescribing in children: a literature review.

Authors:  Shamala Balan; Mohamed Azmi Ahmad Hassali; Vivienne S L Mak
Journal:  World J Pediatr       Date:  2018-09-14       Impact factor: 2.764

Review 2.  Design and conduct of early phase drug studies in children: challenges and opportunities.

Authors:  Michael Rieder; Daniel Hawcutt
Journal:  Br J Clin Pharmacol       Date:  2016-08-08       Impact factor: 4.335

Review 3.  Reported paediatric adverse drug reactions in the UK 2000-2009.

Authors:  Daniel B Hawcutt; Pramod Mainie; Andrew Riordan; Rosalind L Smyth; Munir Pirmohamed
Journal:  Br J Clin Pharmacol       Date:  2012-03       Impact factor: 4.335

Review 4.  Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance.

Authors:  Eva Germovsek; Charlotte I S Barker; Mike Sharland; Joseph F Standing
Journal:  Clin Pharmacokinet       Date:  2019-01       Impact factor: 5.577
  4 in total

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