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Medizinische Forschung an Kindern

Medizinische Forschung an Kindern


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About the Book

English summary: Dorothea Magnus investigates the subject of pharmacological research on children from a legal, medical, ethical and comparative standpoint. She makes practical suggestions as to whether and how medical research on children can and should be done, focusing on the problem of how to promote the best interests of children as a group through research on the one hand while protecting the rights and welfare of individual research subjects on the other hand. On the basis of a comparison with the latest developments in the USA, the author feels that it would be advisable to support drug testing in pediatrics by means of economic incentives such as an extended patent protection or market exclusiveness. German description: Dorothea Magnus untersucht die Arzneimittelforschung an Minderjahrigen aus rechtlicher, medizinischer, ethischer und rechtsvergleichender Sicht. Sie entwickelt praxisgerechte Vorschlage, ob und wie medizinische Forschung an Kindern durchgefuhrt werden kann und sollte, ohne einerseits die Kinder in klinischen Studien unvertretbar zu belasten, aber andererseits die Gruppe der Kinder nicht vom medizinischen Fortschritt auszuschliessen. Die Relevanz des Themas zeigt sich deutlich in der Praxis. Nur etwa 20 % der Arzneimittel auf dem Markt sind an Kindern getestet und fur padiatrische Indikationen zugelassen worden. Der Gebrauch uber die Zulassung hinaus (off-label-use) ist die Folge davon. Die Umsetzung der Richtlinie der EU 2001/20/EG Mitte 2004 hat dieser Situation und der Notwendigkeit klinischer Studien an Kindern in vorsichtigem Umfang Rechnung getragen und zu einer Neufassung des Arzneimittelgesetzes (AMG) gefuhrt. Im Vergleich zu Deutschland haben die US-Regelungen des Modernization Acts von 1997 und der Best Pharmaceuticals for Children Act von 2002 ein komplexes Anreizsystem fur Arzneimittelhersteller geschaffen, nach dem insbesondere der Patentschutz verlangert wird, wenn das Arzneimittel auch fur den Einsatz in der Kinderheilkunde klinisch getestet und seine Verwendung wissenschaftlich abgesichert wird. Das hat zu einer vermehrten Erprobung von Arzneimitteln in der Kinderheilkunde gefuhrt, die auch in Deutschland anzustreben ist.
About the Author: Dorothea Magnus, Geboren 1975; Studium der Rechtswissenschaften in Hamburg und Rom; 2003/2004 Forschungsaufenthalt an der University of San Diego; Referendariat am Hanseatischen Oberlandesgericht; 2006 Promotion.


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Product Details
  • ISBN-13: 9783161490330
  • Publisher: Mohr Siebeck
  • Publisher Imprint: Mohr Siebeck
  • Height: 232 mm
  • No of Pages: 321
  • Series Title: Studien Zum Auslandischen Und Internationalen Privatrecht
  • Weight: 580 gr
  • ISBN-10: 3161490339
  • Publisher Date: 01 Jun 2006
  • Binding: Paperback
  • Language: German
  • Returnable: N
  • Sub Title: Rechtliche, Ethische Und Rechtsvergleichende Aspekte Der Arzneimittelforschung an Kindern
  • Width: 156 mm


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