Global Pediatric Drug Development
ConclusionsGlobal pediatric drug development is a evolving field, and with recent initiatives from the European Medicines Agency and US Food and Drug Administration, this goal is definitively attainable. (Curr Ther Res Clin Exp. 2019; 80:XXX–XXX). (Source: Current Therapeutic Research)
Source: Current Therapeutic Research - February 28, 2019 Category: Drugs & Pharmacology Source Type: research
Bioequivalence of 2 Naproxen Sodium Tablet Formulations in Healthy Male and Female Volunteers
ConclusionsThis single-dose study found that the test product (RB naproxen sodium tablets) and reference product (Aleve naproxen sodium tablets) met the regulatory criteria for bioequivalence in these fasted male and female volunteers; both test and reference products were found to be safe and well tolerated.Graphical Abstract (Source: Current Therapeutic Research)
Source: Current Therapeutic Research - February 21, 2019 Category: Drugs & Pharmacology Source Type: research
Global paediatric drug development
ConclusionsGlobal paediatric drug development is a constantly evolving field, and with recent initiatives from EMA and FDA this goal is definitively attainable. (Source: Current Therapeutic Research)
Source: Current Therapeutic Research - February 13, 2019 Category: Drugs & Pharmacology Source Type: research
Psychiatric and Developmental Effects of Isotretinoin (Retinoid) Treatment for Acne Vulgaris
ConclusionsThe association of isotretinoin exposure with prenatal developmental toxicity is well established. Though numerous reports also link isotretinoin treatment with psychiatric side effects, this association remains controversial. The extent to which isotretinoin influences pediatric and adult development and cognition, and whether and why certain individuals may be susceptible to psychiatric side effects, remains to be clarified. (Source: Current Therapeutic Research)
Source: Current Therapeutic Research - February 10, 2019 Category: Drugs & Pharmacology Source Type: research
North Polar Tube Reduces the Risk of Epistaxis during Nasotracheal Intubation: A prospective, Randomized Clinical Trial
ConclusionsWe conclude that the NPT was associated with less epistaxis and manipulations such as laryngeal compression and head position changes when compared with the ST during nasotracheal intubation. The velvet-soft polyvinyl chloride material of the NPT appears to be responsible for this advantage.Graphical abstract (Source: Current Therapeutic Research)
Source: Current Therapeutic Research - February 9, 2019 Category: Drugs & Pharmacology Source Type: research
Questionable Industry-Sponsored Postneonatal Pediatric Studies in Slovenia
ConclusionsPediatric studies triggered by US and EU regulatory demands are a serious abuse of nonneonatal children and adolescents in Slovenia and worldwide. They are medically redundant at best and often deter patients from effective innovative personalized therapy. They also exclude young patients from reasonable studies. Institutional review boards/ethics committees should be alerted, should critically review all ongoing pediatric studies, should suspend those found to be questionable, and should reject newly submitted questionable ones. (Source: Current Therapeutic Research)
Source: Current Therapeutic Research - February 2, 2019 Category: Drugs & Pharmacology Source Type: research
Global Harmonization of Pediatric Drug Development: Critical for Progress for Developing Safe and Effective Therapeutics for Children
Publication date: Available online 26 January 2019Source: Current Therapeutic ResearchAuthor(s): Andrew E. Mulberg, Timothy CrippsAbstractThe evaluation of "Questionable Industry-Sponsored Studies in children and adolescents in Slovenia" published by XXXX in this issue of Current Therapeutic Research provides an opportunity to discuss evolving US and EU legislative measures to improve available clinical trialderived pediatric data and provide coherent labeling for pediatric providers in dosing of drugs for children. (Source: Current Therapeutic Research)
Source: Current Therapeutic Research - January 26, 2019 Category: Drugs & Pharmacology Source Type: research
The Challenges of Pediatric Drug Development
Publication date: Available online 26 January 2019Source: Current Therapeutic ResearchAuthor(s): Klaus Rose (Source: Current Therapeutic Research)
Source: Current Therapeutic Research - January 26, 2019 Category: Drugs & Pharmacology Source Type: research
Are Regulatory Age Limits in Pediatric Melanoma Justified?
Publication date: Available online 18 January 2019Source: Current Therapeutic ResearchAuthor(s): Klaus Rose, Philip D Walson (Source: Current Therapeutic Research)
Source: Current Therapeutic Research - January 18, 2019 Category: Drugs & Pharmacology Source Type: research
Unusual route of buprenorphine administration: an alternative approach for bypassing adverse drug reactions
Publication date: Available online 18 January 2019Source: Current Therapeutic ResearchAuthor(s): Azadeh Nazari, Shahram Naderi Mazjin, Mansour ShamsipourAbstractTramadol abuse is a critical and growing health concern in Asia. In Iran, tramadol abuse arises most commonly as a result of self-medicating that leads to tramadol dependence. Buprenorphine, a partial agonist of mu opioid receptors approved for the treatment of tramadol dependence, is administered sublingually due to its extensive first-pass metabolism and resulting low oral bioavailability. A 50-year-old man presenting with tramadol dependence after self-medicatin...
Source: Current Therapeutic Research - January 18, 2019 Category: Drugs & Pharmacology Source Type: research
Bioequivalence of Two Naproxen Sodium Tablet Formulations in Healthy Male and Female Subjects
ConclusionsThis single-dose study found that the Test product (RB naproxen sodium tablets) and Reference product (Aleve® naproxen sodium tablets) met the regulatory criteria for bioequivalence in these fasted male and female volunteers; both Test and Reference products were found to be safe and well tolerated.Graphical abstract (Source: Current Therapeutic Research)
Source: Current Therapeutic Research - January 18, 2019 Category: Drugs & Pharmacology Source Type: research
Questionable Industry-Sponsored Post-Neonatal Pediatric Studies in Slovenia
ConclusionsPediatric studies triggered by US and EU regulatory demands are a serious abuse of non-neonatal children and adolescents in Slovenia and worldwide. They are medically redundant at best and often deter patients from effective innovative personalized therapy. They also exclude young patients from reasonable studies. Institutional Review Boards/ ethics committees should be alerted, should critically review all ongoing pediatric studies, should suspend those found to be questionable, and should reject newly submitted questionable ones. (Source: Current Therapeutic Research)
Source: Current Therapeutic Research - January 18, 2019 Category: Drugs & Pharmacology Source Type: research
Population Pharmacokinetic Estimates Suggest Elevated Clearance and Distribution Volume of Desethylamodiaquine in Paediatric Sickle Cell Disease Patients Treated with Artesunate-Amodiaquine
ConclusionsThe data shows a tendency towards lower DEAQ concentration in this limited population of SCD patients and the exploratory population PK estimates suggest altered DEAQ disposition in SCD patients with acute UM. These findings, which if confirmed, may reflect pathophysiological changes associated with SCD, have implications for therapeutic response to amodiaquine in SCD patients. The limited number of recruited SCD patients and sparse sampling approach however, limits extrapolation of the data, and calls for further studies in a larger population. (Source: Current Therapeutic Research)
Source: Current Therapeutic Research - January 12, 2019 Category: Drugs & Pharmacology Source Type: research
Pediatric Drug Development: Challenges and Opportunities
Publication date: Available online 28 December 2018Source: Current Therapeutic ResearchAuthor(s): Cesare Spadoni (Source: Current Therapeutic Research)
Source: Current Therapeutic Research - December 28, 2018 Category: Drugs & Pharmacology Source Type: research
From Research to the Bedside: Challenges for Pediatric Academic Researchers
ConclusionChanges are needed if academicians are to maximize their involvement in pediatric drug and device development. (Source: Current Therapeutic Research)
Source: Current Therapeutic Research - December 28, 2018 Category: Drugs & Pharmacology Source Type: research
