Pediatric drug data in Canadian drug monographs: a descriptive analysis

P Raja, M Duffett, M Mazer-Amirshahi, A Patel… - … Open Access Journal, 2020 - cmajopen.ca
Background: Optimal drug therapy in children relies on the availability of pediatric-specific
information. We aimed to describe the current status of pediatric pharmacotherapy data in …

Documentation of pediatric drug safety in manufacturers' product monographs: a cross-sectional evaluation of the canadian compendium of pharmaceuticals and …

NK Uppal, LL Dupuis, CS Parshuram - Pediatric Drugs, 2008 - Springer
Objective: To describe the provision of pediatric drug safety information in a national
formulary of manufacturers' drug product monographs. Methods: We performed a cross …

A comprehensive list of items to be included on a pediatric drug monograph

LE Kelly, S Ito, D Woods, AJ Nunn… - The Journal of …, 2017 - meridian.allenpress.com
OBJECTIVES Children require special considerations for drug prescribing. Drug information
summarized in a formulary containing drug monographs is essential for safe and effective …

Completion rate and reporting of mandatory pediatric postmarketing studies under the US Pediatric Research Equity Act

TJ Hwang, L Orenstein, AS Kesselheim… - JAMA …, 2019 - jamanetwork.com
Importance Many medicines prescribed to children have not been studied or formally
approved for pediatric use. The Pediatric Research Equity Act of 2003 authorized the US …

Trends in paediatric clinical pharmacology data in US pharmaceutical labelling

S Samiee-Zafarghandy, M Mazer-Amirshahi… - Archives of disease in …, 2014 - adc.bmj.com
Background There is often a lack of safety and efficacy data in the paediatric population at
the time of drug approval. Legislative efforts have promoted clinical pharmacology research …

Access to prescribing information for paediatric medicines in the USA: post‐modernization

L Young, F Lawes, J Tordoff, P Norris… - British journal of clinical …, 2009 - Wiley Online Library
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Children have reduced access to
medicines because of inadequate prescribing information and paucity of suitable …

A landmark report on improving medicines for children

GW't Jong, TP Klassen, SM MacLeod - JAMA pediatrics, 2015 - jamanetwork.com
Children have been classifiedas “therapeutic orphans” for more than 50 years, but the
pediatric community has made important strides toward evidence-based safe and effectivedrugtherapyforchildrenthroughimpr …

Pediatric drug information available at the time of new drug approvals: a cross‐sectional analysis

JD Hudgins, MA Bacho, KL Olsen… - … and drug safety, 2018 - Wiley Online Library
Purpose Greater than 50% of drugs lack pediatric labeling information, resulting in
widespread “off‐label” use in children. To increase pediatric prescribing information, the …

Publication of pediatric and neonatal articles in the pharmacy literature from 2000 to 2010

K Marx, LL Stoudenmire… - American Journal of Health …, 2013 - academic.oup.com
Pediatric patients have traditionally been referred to as “therapeutic orphans” due to the lack
of efficacy, safety, and dosing information provided for this population in the labeling of …

Timing of pediatric drug approval and clinical evidence submitted to regulatory authorities: international comparison among Japan, the United States, and the …

S Hirota, T Yamaguchi - Clinical Pharmacology & Therapeutics, 2020 - Wiley Online Library
Many prescription drugs approved for adult use lack pediatric labeling information, resulting
in their off‐label use in children. Drug regulatory authorities have developed legal and …