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A drug's characteristics make a clear distinction between tissues with high and low blood flow. Enzymatic saturation: When the dose of a drug whose elimination depends on biotransformation is increased above a certain threshold the enzymes responsible for its metabolism become saturated. The drug's plasma concentration will then increase ...
The AUC (from zero to infinity) represents the total drug exposure across time. AUC is a useful metric when trying to determine whether two formulations of the same dose (for example a capsule and a tablet) result in equal amounts of tissue or plasma exposure. Another use is in the therapeutic drug monitoring of drugs with a narrow therapeutic ...
The drug must be found to be effective against the disease for which it is seeking approval (where 'effective' means only that the drug performed better than placebo or competitors in at least two trials). The drug must meet safety criteria by being subject to animal and controlled human testing. Gaining FDA approval usually takes several years.
Therapeutic drug monitoring (TDM) is a branch of clinical chemistry and clinical pharmacology that specializes in the measurement of medication levels in blood.Its main focus is on drugs with a narrow therapeutic range, i.e. drugs that can easily be under- or overdosed. [1]
Processes in pharmacokinetics. ADME is the four-letter abbreviation (acronym) for absorption, distribution, metabolism, and excretion, and is mainly used in fields such as pharmacokinetics and pharmacology.
Topics of pharmacodynamics. Pharmacodynamics (PD) is the study of the biochemical and physiologic effects of drugs (especially pharmaceutical drugs).The effects can include those manifested within animals (including humans), microorganisms, or combinations of organisms (for example, infection).
Statistical analysis plan A statistical analysis plan is a document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data. (ICH E9) Statistical ...
In pharmacokinetics, the drug accumulation ratio (R ac) is the ratio of accumulation of a drug under steady state conditions (i.e., after repeated administration) as compared to a single dose. The higher the value, the more the drug accumulates in the body. An R ac of 1 means no accumulation.