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countries with high patient potential, but be aware of long approval and startup processes). While it’s important to identify sites that will recruit patients consistently, develop contingencies from the start (e.g. 3.Clinical Development Activitiesįrom the start, when developing the protocol, be specific regarding the age of your patients (age at signing ICF, at start treatment or at study completion actual age or enrolment age for age related assessments). Therefore, it’s important to know these elements when developing a protocol. For very young children (0-2 year olds), use a pharmacology model to ensure you factor in the metabolism rate for patients specifically in that age category.įor body size differences (varying by age, weight and height), it’s vital to assess four different factors: Measure blood pressure by using the right cuff size Bladder size is dependent on the development age of the child Both the lung capacity of a child and their GFR (Glomeruler Filtration Rate) have an age element in its formula. Age and weight should be factored intelligently when determining the dose.It’s important to dose patients appropriately according to their age.įor dosing tables, use an adult formulation on child above the age of 12 for 2-11 year olds use a liquid formulation for a volume adjusted dose based on an allometric scale.
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Therefore, you cannot use an adult formulation on children in a trial as you risk an overdose. It’s important to understand that when a child develops from birth to the age of 12, there’s a tenfold increase in body weight, which is crucial. This phase starts with the development of the study protocol. Oral liquidsĢ.Clinical Development Phase – Determining the Dose Visit schedules considering school hours, school holidays.Hospital visits compared to Standard of Care.