Terms & Definitions • 362 stationary phase
In chromatographic methods of analysis, typically, a solid material ( typically modified silica or polymeric material) usually contained in a column, through which a mobile phase is moving. Separation of a mixture of analytes is achieved by differences in partitioning, adsorptive, electrostatic or affinity-type interactions between the mobile and stationary phases.
• 363 steady state
The level of the drug in blood and tissue upon multiple dosing when input and output are at equilibrium during sequential dosing intervals.
• 364 stock solution
Solution containing analyte of interest at a known concentration that can be further diluted to prepare calibration standards and quality control samples (QCs) in biological fluids.
• 365 study director
Has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control.
• 366 study monitor
Responsible for overseeing the progress of a clinical study, and for ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedure (SOP), good clinical practice (GCP) and applicable regulatory requirement(s).
• 367 study plan
A document to describe the purpose and procedure of an experiment or a study. A study plan may supersede standard operating procedure (SOP) requirements.
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