Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered
暂无分享,去创建一个
[1] W. Kraft,et al. Buprenorphine in Neonatal Abstinence Syndrome , 2018, Clinical pharmacology and therapeutics.
[2] M. Farrell,et al. Lessons from the E-Ferol tragedy. , 1986, Pediatrics.
[3] M. Lebel,et al. Benzyl alcohol metabolism and elimination in neonates. , 1988, Developmental pharmacology and therapeutics.
[4] L. Cuzzolin. Neonates exposed to excipients: concern about safety , 2018 .
[5] M. Turner. Neonatal drug development. , 2011, Early human development.
[6] A. Smits,et al. Biochemical tolerance during low dose propylene glycol exposure in neonates: A formulation-controlled evaluation , 2012, DARU Journal of Pharmaceutical Sciences.
[7] J. Gershanik,et al. The gasping syndrome and benzyl alcohol poisoning. , 1982, The New England journal of medicine.
[8] J. N. van den Anker,et al. Neonatal Formulations: The Need for a Tailored, Knowledge Driven Approach. , 2015, Current pharmaceutical design.
[9] J. McElnay,et al. Risk assessment of neonatal excipient exposure: lessons from food safety and other areas. , 2014, Advanced drug delivery reviews.
[10] C. Tuleu,et al. The STEP (safety and toxicity of excipients for paediatrics) database. Part 1-A need assessment study. , 2012, International journal of pharmaceutics.
[11] H. Holst,et al. The Cumulative Daily Tolerance Levels of Potentially Toxic Excipients Ethanol and Propylene Glycol Are Commonly Exceeded in Neonates and Infants , 2018, Basic & clinical pharmacology & toxicology.
[12] D. Tibboel,et al. Non‐maturational covariates for dynamic systems pharmacology models in neonates, infants, and children: Filling the gaps beyond developmental pharmacology , 2017, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[13] T. Metsvaht,et al. Age-Appropriate Formulations Including Pharmaceutical Excipients in Neonatal Medicines. , 2017, Current pharmaceutical design.
[14] D. Fegley,et al. Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients. , 2017, International journal of pharmaceutics.
[15] K. Allegaert,et al. The propylene glycol research project to illustrate the feasibility and difficulties to study toxicokinetics in neonates. , 2012, International journal of pharmaceutics.
[16] M. G. Macdonald,et al. Propylene glycol: increased incidence of seizures in low birth weight infants. , 1987, Pediatrics.
[17] K. Allegaert,et al. Substitution as a Strategy to Improve Excipient Exposure in Neonates: One Piece of the Puzzle , 2016, Pediatric Drugs.
[18] J. Haas,et al. Vasculopathic hepatotoxicity associated with E-Ferol syndrome in low-birth-weight infants. , 1985, JAMA.
[19] D. Field,et al. Toxic additives in medication for preterm infants , 2009, Archives of Disease in Childhood Fetal and Neonatal Edition.
[20] M. Danhof,et al. Developmental pharmacokinetics of propylene glycol in preterm and term neonates. , 2012, British journal of clinical pharmacology.
[21] T. Metsvaht,et al. European Study of Neonatal Exposure to Excipients: an update. , 2013, International journal of pharmaceutics.
[22] K. Naelapää,et al. Hospitalised neonates in Estonia commonly receive potentially harmful excipients , 2012, BMC Pediatrics.
[23] Kristine Svinning Valeur,et al. Safe excipient exposure in neonates and small children - protocol for the SEEN project. , 2017, Danish medical journal.
[24] K. Allegaert,et al. Prospective assessment of short-term propylene glycol tolerance in neonates , 2010, Archives of Disease in Childhood.
[25] J. McElnay,et al. Quantitative analysis of methyl and propyl parabens in neonatal DBS using LC-MS/MS. , 2016, Bioanalysis.
[26] Catherine Tuleu,et al. Guideline on Pharmaceutical Development of Medicines for Paediatric Use , 2008 .
[27] T. Metsvaht,et al. Product Substitution as a Way Forward in Avoiding Potentially Harmful Excipients in Neonates , 2016, Pediatric Drugs.
[28] Natalie M. Pageler,et al. Propylene glycol toxicity in children. , 2014, The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG.
[29] J. McElnay,et al. An Observational Study of Blood Concentrations and Kinetics of Methyl- and Propyl-Parabens in Neonates , 2014, Pharmaceutical Research.
[30] W. Kraft,et al. Ethanol Pharmacokinetics in Neonates and Infants , 2014, Current therapeutic research, clinical and experimental.
[31] M. Turner,et al. Why are Excipients Important to Neonates? , 2015, Current pharmaceutical design.
[32] M. Rieder. Size and Taste Matters: Recent Progress in the Development of Age-Appropriate Medicines for Children , 2018, Pharmaceutical Medicine.
[33] M. Couper,et al. Promoting safety of medicines for children , 2007 .
[34] M. Danhof,et al. The role of population PK–PD modelling in paediatric clinical research , 2010, European Journal of Clinical Pharmacology.
[35] K. Allegaert,et al. Determination of Propylene Glycol in Low Volume Plasma and Urine Samples of Neonates by LC with Photodiode Array Detection , 2011 .
[36] M. Khan,et al. Challenges of pediatric formulations: a FDA science perspective. , 2013, International journal of pharmaceutics.
[37] Inna Chervoneva,et al. Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome , 2017, The New England journal of medicine.
[38] M. G. Macdonald,et al. The potential toxicity to neonates of multivitamin preparations used in parenteral nutrition. , 1987, JPEN. Journal of parenteral and enteral nutrition.
[39] P. Fister,et al. The prevalence and pattern of pharmaceutical and excipient exposure in a neonatal unit in Slovenia , 2015, The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians.
[40] M. Danhof,et al. Low but Inducible Contribution of Renal Elimination to Clearance of Propylene Glycol in Preterm and Term Neonates , 2014, Therapeutic drug monitoring.