Roitman MF, Stuber GD, Phillips PEM, Wightman RM, Carelli RM (2004)
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Services Provided by Lambda: Study design Clinical conduct Protocol development PK Sampling Safety lab evaluations Bioanalysis Pharmacokinetic and Biostatistical analysis CSR preparation and Report Compilation Study Execution Overview Sample Size: 60 healthy adult subjects (Male and Female) 60 healthy adult subjects (Male and Female) Study Duration & Visits ~5 weeks study duration, with multiple outpatient visits for PK sampling ~5 weeks study duration, with multiple outpatient visits for PK sampling Key Safety Measures Implemented (in addition to routine safety parameters) In addition to standard laboratory assessments at screening, specific safety parameters serum lipase and amylase were also evaluated
This includes veins that become more prominent, change color, or start to bulge
