Pediatric Information in Drug Product Labeling

Avant, Debbie·2012·JAMA
DOI 10.1001/jama.2012.3435

Cited by (130)

Items 101–130 of 130

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  3. Drug Safety in Children: Research Studies and Evidence Synthesis
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  4. Analysis of Paediatric Clinical Trial Characteristics and Activity Over 23 Years—Impact of the European Paediatric Regulation on a Single French Clinical Research Center
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  5. Paediatric Drug Development in Japan: Current Status and Future Challenges
    Rieko Inagaki, Mamoru Narukawa · 2024 · Therapeutic Innovation & Regulatory Science
  6. A computational method to quantitatively measure pediatric drug safety using electronic medical records
    Gang Yu, Xian Liang Zeng, Shaoqing Ni, Zheng Jia, Weihong Chen, Xudong Lü, Jiye An, Huilong Duan, Qiang Shu, Haomin Li · 2020 · BMC Medical Research Methodology
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  8. Juvenile Toxicology
    Vanessa Vrolyk, Claudine Tremblay, Catherine A. Picut · 2024 · Springer eBooks
  9. Prescripción off-label de antiasmáticos en Atención Primaria
    Irene Casares Alonso, Alfredo Cano, Alfredo Blanco Quirós, Isabel Pérez García · 2015 · Pediatría Atención Primaria
  10. Pharmacovigilance in Pediatrics
    Ariel Porcalla · 2018 · Elsevier eBooks
  11. The Relationship Between Pharmacogenomics and Pharmacokinetics and Its Impact on Drug Choice and Dosing Regimens in Pediatrics
    Venkata Yellepeddi, Jessica K. Roberts, Leslie Escobar, Casey L. Sayre, Catherine M.T. Sherwin · 2018 · Springer eBooks
  12. Future of Pediatric Sedation
    James R. Miner · 2014 · Springer eBooks
  13. PED-X-Bench: A Benchmark of Adult-to-Pediatric Extrapolation Decisions in FDA Drug Labels
    Srinivasan, Apoorva, Berkowitz, Jacob, Friedrich, Nadine A., Tsang, Kevin, Kuchi, Aditi, Acitores, José, Zietz, Michael, Czarny, Ryan S., Liu, Hongyu, Tatonetti, Nicholas P. · 2025 · medRxiv
  14. Medical-legal aspects of the fungal infection drug therapy in neonatology: evidence-based medicine and off-label prescribing
    Marta Ciuffi, Francesco Paribello, Roberto Demontis, Ernesto d’Aloja, Roberta Massa · 2014 · Journal of pediatric and neonatal individualized medicine
  15. Pediatric Formulations and Dosage Forms and Future Opportunities: Impact of Regulations in the USA and Implementation of Quality by Design
    Arzu Selen · 2014 · AAPS advances in the pharmaceutical sciences series
  16. Safeguards for Minors in Clinical Research: An IRB Perspective
    Mitali Wadekar, Anil Prakash Sharma, Gina Battaglia · 2014
  17. Consequences of a lack of adult intravenous data on the prediction accuracy of pediatric physiologically based pharmacokinetic (PBPK) modeling
    Rabiya Chandani · 2015 · UWSpace (University of Waterloo)
  18. Drug Safety in Children: Research Studies and Evidence Synthesis
    Shamala Balan, Rabia Hussain, Siew Chin Ong, Zaheer-Ud-Din Babar · 2023 · Springer eBooks
  19. Advances in Pediatric Pharmacology, Therapeutics, and Toxicology
    Ian M. Paul, Cheston M. Berlin · 2003 · Advances in Pediatrics
  20. The Relationship Between Pharmacogenomics and Pharmacokinetics and Its Impact on Drug Choice and Dosing Regimens in Pediatrics
    Jessica K. Roberts, Leslie Escobar, Catherine M.T. Sherwin · 2024 · Springer eBooks
  21. Juvenile Toxicology
    Vanessa Vrolyk, Claudine Tremblay, Catherine A. Picut · 2023 · Springer eBooks
  22. Historical perspective
    Pauline De Bruyne, Shinya Ito, Facundo Garcia-Bournissen · 2024 · Elsevier eBooks
  23. Safe Prescribing and Monitoring in Pediatrics
    Jeremy S. Stultz, Milap C. Nahata · 2024 · Springer eBooks
  24. Harmonizing the methodology and metrics definitions across pediatric clinical trials networks, an important step towards better health outcomes in children
    Max J. Coppes · 2024 · Pediatric Research
  25. Pharmacovigilance in Pediatrics
    Ariel Porcalla, Douglas George Ashley · 2025 · Elsevier eBooks
  26. Recent Utilization of Pediatric Extrapolation and Modeling and Simulation Approaches in Pediatric Drug Development in Japan
    Akinori Nakashima, Akihide Tsujimoto, Masako Saitō, Jun Takeda, Makiko Natori, Satoshi Shoji · 2025 · The Journal of Clinical Pharmacology
  27. Breakthroughs in Solubility Optimization for Pediatric Drug Formulations
    Mays Fadhil Mohammed-Kadhum, Ghaidaa Sulaiman Hameed, Zainab H. Mahdi · 2025 · Al Mustansiriyah Journal of Pharmaceutical Sciences
  28. The rational use of available evidence before extrapolating the benefit risk ratio from adults to children
    P. Janiaud · 2017
  29. Consequence of prescriptions with andwithout marketing authorization after hospitalization in children
    Elham Jaberi · 2022
  30. Advances in Pediatric Pharmacology, Therapeutics, and Toxicology
    Daniel Gonzalez, Ian M. Paul, Daniel K. Benjamin, Michael Cohen-Wolkoweiz · 2014 · Advances in Pediatrics