Juvenile animal studies for the development of paediatric medicines: a description and conclusions from a European Medicines Agency workshop on juvenile animal testing for nonclinical assessors

Birth Defects Research. Part B, Developmental and Reproductive Toxicology
Beatriz Silva-LimaAgnes Saint-Raymond

Abstract

A workshop organised by the European Medicines Agency involved assessors and experts present in a Nonclinical Working Group evaluating juvenile animal studies for Paediatric Investigation Plans in collaboration with the Paediatric Committee and the Safety Working Party of the Committee for Human Medicinal Products. The objective of the workshop was to analyse which juvenile animal studies proposals were received and agreed by the Paediatric Committee, to check consistency and how to apply the existing European guideline on juvenile animal studies. A comparison of main organ system development in man vs. animal species was presented to guide the review and to support species selection and protocol design. An analysis of juvenile animal studies included in finalised PIP's was also presented. Out of 109 paediatric investigation plans finalised between November 2008 and March 2009, 43 included one or more juvenile animal studies. In most cases the preferred species was the rat; one species only was requested to be studied (20/22), but in a minority two species were required (2/22). When deciding on the characteristics of the juvenile animal studies, such as age of animals at study start, the age of the children targeted by the medi...Continue Reading

References

Jan 1, 1993·Developmental Neuroscience·J B ClarkJ M Land
Oct 4, 2000·Physiological Reviews·J Pácha
Oct 16, 2002·Drug and Chemical Toxicology·Elise M LewisMildred S Christian
Jul 11, 2003·Annals of the New York Academy of Sciences·Petra BittigauChrysanthy Ikonomidou
Jul 18, 2003·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Tracey ZoetisMark E Hurtt
Jul 18, 2003·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Tracey Zoetis, Mark E Hurtt
Jul 18, 2003·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Tracey Zoetis, Mark E Hurtt
Jul 18, 2003·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·M Sue MartyBjorn A Thorsrud
Jul 18, 2003·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·David A Beckman, Maureen Feuston
Jan 28, 2004·Annual Review of Pharmacology and Toxicology·Lucio G CostaOffie Porat Soldin
Apr 19, 2005·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Karen WalthallTracey Zoetis
Oct 27, 2006·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Rebecca E WatsonGregg D Cappon

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Citations

Jul 14, 2012·Toxicological Sciences : an Official Journal of the Society of Toxicology·Melissa RhodesAshlyn Eaton Bassiri
Mar 8, 2012·Bioanalysis·Tomasz GrabowskiJerzy Jan Jaroszewski
May 20, 2011·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Gregg D Cappon
May 20, 2011·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Christopher J BowmanDavid M Cross
May 20, 2011·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Dinah M Duarte, Beatriz Silva-Lima
Jun 4, 2011·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Jacqueline Carleer, Janina Karres
May 25, 2012·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·Isabelle LeconteMark Hurtt
Jul 20, 2011·Birth Defects Research. Part B, Developmental and Reproductive Toxicology·LaRonda L MorfordTimothy P Coogan
Jan 15, 2014·Stress : the International Journal on the Biology of Stress·Franz VeruSuzanne King
Apr 8, 2014·International Journal of Pharmaceutics·Gesine Winzenburg
Feb 22, 2014·Advanced Drug Delivery Reviews·M A TurnerUNKNOWN Global Research in Paediatrics
Jul 31, 2013·Regulatory Toxicology and Pharmacology : RTP·Paul Baldrick
Oct 31, 2012·Regulatory Toxicology and Pharmacology : RTP·Liane Soellner, Klaus Olejniczak
Oct 28, 2010·Journal of Pharmacokinetics and Pharmacodynamics·Carl C Peck
Apr 6, 2016·AAPS PharmSciTech·J Carolina VisserHenderik W Frijlink
Jan 1, 2017·EJNMMI Radiopharmacy and Chemistry·J KoziorowskiT L Mindt
May 17, 2018·Clinical Reviews in Allergy & Immunology·Marcella Aquino, Greg Rosner
Aug 15, 2012·European Journal of Clinical Pharmacology·J Simon BellSirpa Hartikainen
May 7, 2011·Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz·J KarresA Saint Raymond
Jan 10, 2013·Korean journal of pediatrics·Seung Youn KimDong Ho Kim
Aug 17, 2018·Pediatric Nephrology : Journal of the International Pediatric Nephrology Association·Brian R Stotter, Michael A Ferguson
Feb 17, 2019·Drug Metabolism and Disposition : the Biological Fate of Chemicals·Luc M De SchaepdrijverConnie L Chen
May 2, 2018·Therapeutic Innovation & Regulatory Science·Paul Baldrick
Dec 15, 2020·Birth Defects Research·Lorraine M Posobiec, Susan B Laffan
Dec 6, 2020·Cancer Discovery·Theodore W LaetschLucas Moreno

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