Changes in Drug Development Regulations and Their Impact on Clinical Trials | | 2022 |
Extrapolation as a Default Strategy in Pediatric Drug Development. | Therapeutic Innovation and Regulatory Science | 2022 |
Survey on Off-Label Use of Antineoplastic Agents in Pediatric Patients using a Large-scale Medical Database in Japan | Japanese Journal of Clinical Pharmacology and Therapeutics | 2020 |
Pharmacologic Treatment of Pediatric Hypertension | | 2018 |
Changes in Drug Development Regulations and Their Impact on Clinical Trials | | 2018 |
Encyclopedia of AIDS | | 2018 |
Pharmacologic Treatment of Pediatric Hypertension | | 2017 |
Encyclopedia of AIDS | | 2016 |
Changes in Drug Development Regulations and Their Impact on Clinical Trials | | 2016 |
Pediatric Formulations and Dosage Forms and Future Opportunities: Impact of Regulations in the USA and Implementation of Quality by Design | AAPS Advances in the Pharmaceutical Sciences Series | 2014 |
Pharmacologic Treatment of Childhood Hypertension | | 2013 |
Pediatric Clinical Trials in Mainland China Over the Past Decade (From 2009 to 2020) | Frontiers in Medicine | 2021 |
The Best Pharmaceuticals for Children Act and Pediatric Research Equity Act reach the age of majority-An oncology perspective | Pediatric Blood and Cancer | 2021 |
Drug Safety in Labeling for Pediatric Drug Development and Dose Selection in Submissions to the US Food and Drug Administration | Journal of Clinical Pharmacology | 2021 |
When should we start and stop ACEi/ARB in paediatric chronic kidney disease? | Pediatric Nephrology | 2021 |
Off-label use of prescription analgesics among hospitalized children in the United States | Pharmacoepidemiology and Drug Safety | 2020 |
Dosing Recommendations for Pediatric Patients With Renal Impairment | Journal of Clinical Pharmacology | 2020 |
International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States | Clinical Pharmacology and Therapeutics | 2020 |
Development of Therapeutics for Children-A Tricky Balancing Act | JAMA Pediatrics | 2019 |
Tiny and Forgotten: A Call for Focused Neonatal Policy Reform | Therapeutic Innovation and Regulatory Science | 2019 |
Pharmacometric Modeling and Simulation Is Essential to Pediatric Clinical Pharmacology | Journal of Clinical Pharmacology | 2018 |
Effect of renal function on antihypertensive drug safety and efficacy in children | Pediatric Nephrology | 2018 |
Neonatal Safety Information Reported to the FDA During Drug Development Studies | Therapeutic Innovation and Regulatory Science | 2017 |
Pediatric drug information available at the time of new drug approvals: A cross-sectional analysis | Pharmacoepidemiology and Drug Safety | 2018 |
Facilitators and barriers to the successful implementation of pediatric antibacterial drug trials: Findings from CTTI's survey of investigators | Contemporary Clinical Trials Communications | 2018 |
Recommendations to Enhance Pediatric Cardiovascular Drug Development: Report of a Multi-Stakeholder Think Tank | Journal of the American Heart Association | 2018 |
2017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning From Sildenafil | Circulation: Cardiovascular Quality and Outcomes | 2017 |
2017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning From Sildenafil | Journal of the American College of Cardiology | 2017 |
Advances in Pediatric Pharmacology, Therapeutics, and Toxicology | Advances in Pediatrics | 2016 |
A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013 | Therapeutic Innovation and Regulatory Science | 2016 |
Food and Drug Administration Requirements for Clinical Studies in Pediatric Patients | Therapeutic Innovation and Regulatory Science | 2015 |
Anesthetic use in newborn infants: the urgent need for rigorous evaluation | Pediatric Research | 2015 |
Drug-induced renal damage in preterm neonates: state of the art and methods for early detection | Drug Safety | 2015 |
Adverse Event Detection and Labeling in Pediatric Drug Development: Antiretroviral Drugs | Therapeutic Innovation and Regulatory Science | 2015 |
Ethics of drug studies in the newborn | Paediatric Drugs | 2015 |
Clinical trials in children | British Journal of Clinical Pharmacology | 2015 |
A Survey of Neonatal Pharmacokinetic and Pharmacodynamic Studies in Pediatric Drug Development | Clinical Pharmacology and Therapeutics | 2015 |
Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database | Cardiology in the Young | 2015 |
Pharmacological options for BPD prevention: steps for better clinical trial design | Journal of Perinatology | 2014 |
Treatment of Pediatric Hypertension: Lessons Learned from Recent Clinical Trials | Current Cardiovascular Risk Reports | 2014 |
Paediatric oral biopharmaceutics: key considerations and current challenges | Advanced Drug Delivery Reviews | 2014 |
Optimising medicines for children: considerations for clinical pharmacists | European Journal of Hospital Pharmacy | 2014 |
Changing the outcomes of pediatric drug trials: APNs making a difference | Journal of Pediatric Health Care | 2013 |
Antihypertensive drug use by children: are the drugs labeled and indicated? | Journal of Clinical Hypertension | 2012 |