Concern with potential toxicity due to the widespread use of unlicensed and off label drugs in children has led to regulatory changes aimed to strengthen the evidence base for paediatric drugs. This thesis examines paediatric randomised controlled trials (RCTs), the highest level of evidence, and assesses them in relation to global child health. A systematic review was performed using validated methods to search three major databases for paediatric RCTs published in 2007. More than 600 RCTs were identified involving more than 100,000 children. The RCTs appear to study the appropriate clinical areas however few studies involved neonates. The RCTs also seem to be of good methodological quality with a mean Jadad score of 3.22. The reporti...
Background: Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited...
Background: Current legislations such as paediatric investigation plan (PIP) require pharmaceutical ...
Children often have to accept treatments based on what is known to work in adults. Many efforts are ...
Background: There is now greater involvement of children in drug trials to ensure that paediatric me...
Children were acknowledged as ‘therapeutic or pharmaceutical orphans’ in 1960s, since then there has...
There are limited data on incidences of drug related problems (DRPs) including adverse drug reaction...
There are limited data on incidences of drug related problems (DRPs) including adverse drug reaction...
OBJECTIVE: Randomised controlled trials (RCT) offer an opportunity to learn about frequency and char...
Ethics and recruitment issues Evidence-based medicine and healthcare are the pillar of optimal medic...
There have been numerous studies to show that many of the medicines used in children are used off-la...
Paediatric clinical pharmacology is the scientific study of medicines in children and is a relativel...
The development of specific drug therapy for children was a paradigm-changing event that transformed...
Introduction: For more than two decades several initiatives have emerged to increase recruitment of ...
Drug toxicity is, unfortunately, a significant problem in children both in the hospital and in the c...
The facilitation of tight regulatory frameworks necessary to ensure that new drugs are safe and effe...
Background: Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited...
Background: Current legislations such as paediatric investigation plan (PIP) require pharmaceutical ...
Children often have to accept treatments based on what is known to work in adults. Many efforts are ...
Background: There is now greater involvement of children in drug trials to ensure that paediatric me...
Children were acknowledged as ‘therapeutic or pharmaceutical orphans’ in 1960s, since then there has...
There are limited data on incidences of drug related problems (DRPs) including adverse drug reaction...
There are limited data on incidences of drug related problems (DRPs) including adverse drug reaction...
OBJECTIVE: Randomised controlled trials (RCT) offer an opportunity to learn about frequency and char...
Ethics and recruitment issues Evidence-based medicine and healthcare are the pillar of optimal medic...
There have been numerous studies to show that many of the medicines used in children are used off-la...
Paediatric clinical pharmacology is the scientific study of medicines in children and is a relativel...
The development of specific drug therapy for children was a paradigm-changing event that transformed...
Introduction: For more than two decades several initiatives have emerged to increase recruitment of ...
Drug toxicity is, unfortunately, a significant problem in children both in the hospital and in the c...
The facilitation of tight regulatory frameworks necessary to ensure that new drugs are safe and effe...
Background: Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited...
Background: Current legislations such as paediatric investigation plan (PIP) require pharmaceutical ...
Children often have to accept treatments based on what is known to work in adults. Many efforts are ...