Warning: Undefined array key "mm" in /www/wwwroot/www.ai-bt.com/si.php on line 10 Deprecated: trim(): Passing null to parameter #1 ($string) of type string is deprecated in /www/wwwroot/www.ai-bt.com/si.php on line 10 Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials.

Literature DB >> 31708158

Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials.

Jonathan M Davis¹, Gerri R Baer², Susan McCune², Agnes Klein³, Junko Sato⁴, Laura Fabbri⁵, Alexandra Mangili⁶, Mary A Short⁷, Susan Tansey⁸, Barry Mangum⁹, Isamu Hokuto¹⁰, Hidefumi Nakamura¹¹, Thomas Salaets¹², Karel Allegaert¹³, Lynne Yao¹⁴, Michael Blum¹⁴, Joseph Toerner¹⁴, Mark Turner¹⁵, Ron Portman¹⁶.

Abstract

Entities: Chemical Disease Gene Species

Mesh：

Year: 2019 PMID： 31708158 PMCID： PMC7096275 DOI： 10.1016/j.jpeds.2019.09.060

Source DB: PubMed Journal: J Pediatr ISSN： 0022-3476 Impact factor: 4.406

× No keyword cloud information.

13 in total

1. The Pediatrix BabySteps Data Warehouse and the Pediatrix QualitySteps improvement project system--tools for "meaningful use" in continuous quality improvement.

Authors: Alan R Spitzer; Dan L Ellsbury; Darren Handler; Reese H Clark
Journal: Clin Perinatol Date: 2010-03 Impact factor: 3.430

2. Newborns, one of the last therapeutic orphans to be adopted.

Authors: Justin L Stiers; Robert M Ward
Journal: JAMA Pediatr Date: 2014-02 Impact factor: 16.193

Review 3. 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

4. Quantifying the magnitude and cost of collecting extraneous protocol data.

Authors: Kenneth A Getz; Stella Stergiopoulos; Michelle Marlborough; Jane Whitehill; Marla Curran; Kenneth I Kaitin
Journal: Am J Ther Date: 2015 Mar-Apr Impact factor: 2.688

5. Streamlining Safety Data Collection in Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Trials: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team.

Authors: Helen Donnelly; Demissie Alemayehu; Radu Botgros; Sabrina Comic-Savic; Barry Eisenstein; Benjamin Lorenz; Kunal Merchant; Eric Pelfrene; Christina Reith; Jonas Santiago; Rosemary Tiernan; Richard Wunderink; Pamela Tenaerts; Charles Knirsch
Journal: Clin Infect Dis Date: 2016-08-15 Impact factor: 9.079

Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials.

1. The Pediatrix BabySteps Data Warehouse and the Pediatrix QualitySteps improvement project system--tools for "meaningful use" in continuous quality improvement.

2. Newborns, one of the last therapeutic orphans to be adopted.

Review 3. Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates.

4. Quantifying the magnitude and cost of collecting extraneous protocol data.

5. Streamlining Safety Data Collection in Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Trials: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team.

6. The International Neonatal Consortium: collaborating to advance regulatory science for neonates.

7. Reporting on data monitoring committees in neonatal randomised controlled trials is inconsistent.

8. Unlicensed and Off-Label Medication Use in Pediatric and Neonatal Intensive Care Units: No Change Over a Decade.

9. Large differences in neonatal drug use between NICUs are common practice: time for consensus?

10. Use of off-label and unlicensed medicines in neonatal intensive care.

1. Amikacin or Vancomycin Exposure Alters the Postnatal Serum Creatinine Dynamics in Extreme Low Birth Weight Neonates.

Review 2. Dose-Related Adverse Drug Events in Neonates: Recognition and Assessment.