Terms & Definitions • 304 protein binding


The binding of compounds, with typical reference to xenobiotics, to large plasma proteins such as albumin. The extent of protein binding of a drug varies according to the chemistry of the drug itself and certain disease states, and only the unbound fraction is considered to be freely able to move into tissues or have activity with cellular surface receptors.


• 305 protein precipitation


A process for removing proteins from sample matrices involving aggregation and precipitation of proteins by adding a solvent or reagent, often using an organic solvent or strongly acidic solution.


• 306 protein therapeutics


Proteins that are typically manufactured in the laboratory for therapeutic use.


• 307 protocol


A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial or a study. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.


• 308 protocol amendment


Documentation of an intended change to the study plan after the study initiation date.


• 309 protocol deviation


Documentation of an unintended departure from the study plan after the study initiation date.


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