Literature DB >> 30536691

Paediatric extrapolation: the panacea for paediatric drug development?

John van den Anker1,2.   

Abstract

Keywords:  EMA; FDA; developmental pharmacology; neonates; paediatric extrapolation; paediatrics

Mesh：

Year:  2019        PMID： 30536691      PMCID： PMC6422645          DOI： 10.1111/bcp.13836

Source DB:  PubMed          Journal:  Br J Clin Pharmacol        ISSN： 0306-5251            Impact factor:   4.335


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  11 in total

1.  Predicting neonatal pharmacokinetics from prior data using population pharmacokinetic modeling.

Authors:  Jian Wang; Andrea N Edginton; Debbie Avant; Gilbert J Burckart
Journal:  J Clin Pharmacol       Date:  2015-06-09       Impact factor: 3.126

2.  Paediatric extrapolation: the panacea for paediatric drug development?

Authors:  John van den Anker
Journal:  Br J Clin Pharmacol       Date:  2019-01-04       Impact factor: 4.335

Review 3.  Developmental Changes in Pharmacokinetics and Pharmacodynamics.

Authors:  John van den Anker; Michael D Reed; Karel Allegaert; Gregory L Kearns
Journal:  J Clin Pharmacol       Date:  2018-10       Impact factor: 3.126

4.  Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA.

Authors:  Dionna J Green; Janelle M Burnham; Paul Schuette; Xiaomei I Liu; Brian M Maas; Lynne Yao; Susan K McCune; Joseph Chen; John N van den Anker; Gilbert J Burckart
Journal:  J Clin Pharmacol       Date:  2018-04-17       Impact factor: 3.126

5.  Pediatric Drug Development: Outlook for Science-Based Innovation.

Authors:  Dionna J Green; Issam Zineh; Gilbert J Burckart
Journal:  Clin Pharmacol Ther       Date:  2018-01-31       Impact factor: 6.875

6.  Simultaneous pharmacokinetic modeling of gentamicin, tobramycin and vancomycin clearance from neonates to adults: towards a semi-physiological function for maturation in glomerular filtration.

Authors:  Roosmarijn F W De Cock; Karel Allegaert; Janneke M Brussee; Catherine M T Sherwin; Hussain Mulla; Matthijs de Hoog; Johannes N van den Anker; Meindert Danhof; Catherijne A J Knibbe
Journal:  Pharm Res       Date:  2014-05-02       Impact factor: 4.200

7.  Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned.

Authors:  Haihao Sun; Jean W Temeck; Wiley Chambers; Ginger Perkins; Renan Bonnel; Dianne Murphy
Journal:  Ther Innov Regul Sci       Date:  2017-08-18       Impact factor: 1.778

Review 8.  A Review of the New Antiepileptic Drugs for Focal-Onset Seizures in Pediatrics: Role of Extrapolation.

Authors:  Alexis Arzimanoglou; O'Neill D'Cruz; Douglas Nordli; Shlomo Shinnar; Gregory L Holmes
Journal:  Paediatr Drugs       Date:  2018-06       Impact factor: 3.022

9.  Extrapolation of praziquantel pharmacokinetics to a pediatric population: a cautionary tale.

Authors:  Peter L Bonate; Tianli Wang; Paul Passier; Wilhelmina Bagchus; Howard Burt; Christian Lüpfert; Nada Abla; Jana Kovac; Jennifer Keiser
Journal:  J Pharmacokinet Pharmacodyn       Date:  2018-09-14       Impact factor: 2.745

10.  Drugs Being Eliminated via the Same Pathway Will Not Always Require Similar Pediatric Dose Adjustments.

Authors:  Elisa A M Calvier; Elke H J Krekels; Huixin Yu; Pyry A J Välitalo; Trevor N Johnson; Amin Rostami-Hodjegan; Dick Tibboel; Piet H van der Graaf; Meindert Danhof; Catherijne A J Knibbe
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2018-02-05
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  3 in total

1.  Paediatric extrapolation: the panacea for paediatric drug development?

Authors:  John van den Anker
Journal:  Br J Clin Pharmacol       Date:  2019-01-04       Impact factor: 4.335

Review 2.  Developmental Pharmacodynamics and Modeling in Pediatric Drug Development.

Authors:  Laurie S Conklin; Eric P Hoffman; John van den Anker
Journal:  J Clin Pharmacol       Date:  2019-09       Impact factor: 3.126

Review 3.  Quantitative system pharmacology as a legitimate approach to examine extrapolation strategies used to support pediatric drug development.

Authors:  Karim Azer; Jeffrey S Barrett
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2022-05-24
  3 in total

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