Laboratory school protocol — ADHD Practical Guide / Tris Pharma Medical Affairs

Study designs Study Designs Study Designs

Bias refers to systematic errors that result from the way the study was designed, executed, or interpreted

Uses “cycles of time” to equally expose subjects to different settings in a repeated way across the day
- For ADHD studies, subjects cycle between the analogue classroom and structured activities
- Uses age and developmentally appropriate activities and environmental modifications for preschool and school-aged children
Allows for systematic collection of information deemed to be critical in the standard clinical practice of treating disruptive behavior disorders with medication
- Dosing, safety, attention, behavior, and classroom productivity
Pharmacodynamic (PD) and pharmacokinetic (PK) information can be collected simultaneously
Safety measurements include pulse rate, blood pressure, electrocardiogram, and side effect ratings

The application of the LSP to the development of stimulant treatments for ADHD is well documented

Uses “cycles of time” to equally expose subjects to different settings in a repeated way across the day

– For ADHD studies, subjects cycle between the analogue classroom and structured activities
– Uses age and developmentally appropriate activities and environmental modifications for preschool and school-aged children

Allows for systematic collection of information deemed to be critical in the standard clinical practice of treating disruptive behavior disorders with medication

– Dosing, safety, attention, behavior, and classroom productivity

Pharmacodynamic (PD) and pharmacokinetic (PK) information can be collected simultaneously

Safety measurements include pulse rate, blood pressure, electrocardiogram, and side effect ratings

*Also called the analogue laboratory classroom

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Laboratory school protocol

Adult workplace environment Pharmacokinetic studies Basic PK measurements