Literature DB >> 29173779

Development of Drug Therapies for Newborns and Children: The Scientific and Regulatory Imperatives.

Yeruk Lily Mulugeta1, Anne Zajicek2, Jeff Barrett3, Hari Cheryl Sachs4, Susan McCune4, Vikram Sinha5, Lynne Yao4.   

Abstract

Pediatric legislation has generated information about the efficacy, safety, and dosing of more than 600 products in children. Extrapolation of adult efficacy data has been an integral part of pediatric drug development. Advances in our understanding of physiology and pharmacology have improved the approach to pediatric dose selection. However, a high percentage of pediatric trials do not meet their primary efficacy endpoint. Delays in initiating completing pediatric studies persist. This article describes these advances and provides innovative approaches to optimize pediatric drug development.
Copyright © 2017 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Dosing; Extrapolation; Neonatal; Pediatric; Regulations; Research

Mesh：

Year:  2017        PMID： 29173779      PMCID： PMC5765998          DOI： 10.1016/j.pcl.2017.08.015

Source DB:  PubMed          Journal:  Pediatr Clin North Am        ISSN： 0031-3955            Impact factor:   3.278


  20 in total

1.  Extrapolation of adult data and other data in pediatric drug-development programs.

Authors:  Julia Dunne; William J Rodriguez; M Dianne Murphy; B Nhi Beasley; Gilbert J Burckart; Jane D Filie; Linda L Lewis; Hari C Sachs; Philip H Sheridan; Peter Starke; Lynne P Yao
Journal:  Pediatrics       Date:  2011-10-24       Impact factor: 7.124

2.  Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006.

Authors:  V A Bhattaram; C Bonapace; D M Chilukuri; J Z Duan; C Garnett; J V S Gobburu; S H Jang; L Kenna; L J Lesko; R Madabushi; Y Men; J R Powell; W Qiu; R P Ramchandani; C W Tornoe; Y Wang; J J Zheng
Journal:  Clin Pharmacol Ther       Date:  2007-02       Impact factor: 6.875

3.  Failed Pediatric Drug Development Trials.

Authors:  J D Momper; Y Mulugeta; G J Burckart
Journal:  Clin Pharmacol Ther       Date:  2015-06-26       Impact factor: 6.875

Review 4.  Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates.

Authors:  Robert M Ward; Daniel Benjamin; Jeffrey S Barrett; Karel Allegaert; Ronald Portman; Jonathan M Davis; Mark A Turner
Journal:  Pediatr Res       Date:  2016-11-03       Impact factor: 3.756

5.  Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials.

Authors:  R Leong; M L T Vieira; P Zhao; Y Mulugeta; C S Lee; S-M Huang; G J Burckart
Journal:  Clin Pharmacol Ther       Date:  2012-05       Impact factor: 6.875

6.  Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy.

Authors:  Gerold T Wharton; M Dianne Murphy; Debbie Avant; John V Goldsmith; Grace Chai; William J Rodriguez; Eric L Eisenstein
Journal:  Pediatrics       Date:  2014-07-14       Impact factor: 7.124

Review 7.  Challenges and considerations for development of therapeutic proteins in pediatric patients.

Authors:  Yi Zhang; Xiaohui Wei; Gaurav Bajaj; Jeffrey S Barrett; Bernd Meibohm; Amita Joshi; Manish Gupta
Journal:  J Clin Pharmacol       Date:  2015-03       Impact factor: 3.126

8.  Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study.

Authors:  S Turner; A J Nunn; K Fielding; I Choonara
Journal:  Acta Paediatr       Date:  1999-09       Impact factor: 2.299

9.  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

10.  Pediatric antihypertensive trial failures: analysis of end points and dose range.

Authors:  Daniel K Benjamin; P Brian Smith; Pravin Jadhav; Jogarao V Gobburu; M Dianne Murphy; Vic Hasselblad; Carissa Baker-Smith; Robert M Califf; Jennifer S Li
Journal:  Hypertension       Date:  2008-03-10       Impact factor: 10.190
View more
  7 in total

Review 1.  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

2.  A Sponsor's View on Postmarketing Regulatory Commitments Involving Human Drug Products.

Authors:  Laura McKinley; Milton L Pressler; Mary A Hiatt; William Gregory
Journal:  Clin Pharmacol Ther       Date:  2021-07-12       Impact factor: 6.903

3.  Pharmacogenomic Testing In Pediatrics: Navigating The Ethical, Social, And Legal Challenges.

Authors:  Susanne B Haga
Journal:  Pharmgenomics Pers Med       Date:  2019-10-14

4.  The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech Republic.

Authors:  L Horavova; K Nebeska; L Souckova; R Demlova; P Babula
Journal:  Ther Innov Regul Sci       Date:  2020-06-05       Impact factor: 1.778

5.  Physiologically-Based Pharmacokinetic Modeling of Remdesivir and Its Metabolites to Support Dose Selection for the Treatment of Pediatric Patients With COVID-19.

Authors:  Justin D Lutz; Anita Mathias; Polina German; Cheryl Pikora; Sunila Reddy; Brian J Kirby
Journal:  Clin Pharmacol Ther       Date:  2021-03-10       Impact factor: 6.875

Review 6.  Informed consent for neonatal trials: practical points to consider and a check list.

Authors:  Beate Aurich; Eric Vermeulen; Valéry Elie; Mariette H E Driessens; Christine Kubiak; Donato Bonifazi; Evelyne Jacqz-Aigrain
Journal:  BMJ Paediatr Open       Date:  2020-12-29

7.  Physiologically-based pharmacokinetic modeling of nafamostat to support dose selection for treatment of pediatric patients with COVID-19.

Authors:  Yong-Soon Cho; Jae-Gook Shin
Journal:  Transl Clin Pharmacol       Date:  2022-03-09
  7 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.