Literature DB >> 18454567

The new European regulation on pediatric medicines: safety and ethics perspectives.

Antje Neubert, Claire Planner, Noel Cranswick.   

Abstract

Mesh：

Year:  2008        PMID： 18454567     DOI： 10.2165/00148581-200810030-00003

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


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  14 in total

1.  Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

Authors: 
Journal:  Med Etika Bioet       Date:  2002 Spring-Summer

2.  Supply problems of unlicensed and off-label medicines after discharge.

Authors:  I C K Wong; N Basra; V W Yeung; Judith Cope
Journal:  Arch Dis Child       Date:  2006-05-22       Impact factor: 3.791

3.  How informed is signed consent?

Authors:  D J Byrne; A Napier; A Cuschieri
Journal:  Br Med J (Clin Res Ed)       Date:  1988-03-19

4.  Effect of the pediatric exclusivity provision on children's access to medicines.

Authors:  Joanne Grieve; June Tordoff; David Reith; Pauline Norris
Journal:  Br J Clin Pharmacol       Date:  2005-06       Impact factor: 4.335

5.  Informed consent: study of quality of information given to participants in a clinical trial.

Authors:  N Lynöe; M Sandlund; G Dahlqvist; L Jacobsson
Journal:  BMJ       Date:  1991-09-14

6.  Development of children's assent documents using a child-centred approach.

Authors:  Karen Ford; Judy Sankey; Jackie Crisp
Journal:  J Child Health Care       Date:  2007-03       Impact factor: 1.979

7.  The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients.

Authors:  Antje Neubert; Harald Dormann; Jutta Weiss; Tobias Egger; Manfred Criegee-Rieck; Wolfgang Rascher; Kay Brune; Burkhard Hinz
Journal:  Drug Saf       Date:  2004       Impact factor: 5.606

8.  Informed consent: how much does the patient understand?

Authors:  J H Bergler; A C Pennington; M Metcalfe; E D Freis
Journal:  Clin Pharmacol Ther       Date:  1980-04       Impact factor: 6.875

9.  Child assent and parental permission in pediatric research.

Authors:  Wilma C Rossi; William Reynolds; Robert M Nelson
Journal:  Theor Med Bioeth       Date:  2003

10.  Informed consent in children and adolescents: age, maturation and psychological state.

Authors:  L D Dorn; E J Susman; J C Fletcher
Journal:  J Adolesc Health       Date:  1995-03       Impact factor: 5.012
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  1 in total

1.  Drug utilisation on a preterm and neonatal intensive care unit in Germany: a prospective, cohort-based analysis.

Authors:  Antje Neubert; Kristin Lukas; Thomas Leis; Harald Dormann; Kay Brune; Wolfgang Rascher
Journal:  Eur J Clin Pharmacol       Date:  2009-09-16       Impact factor: 2.953
  1 in total

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