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Per protocol set
Per protocol set (valid cases, efficacy sample, evaluable subjects sample) the set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of major protocol violations. See also full analysis set.
RELATED TERMS--------------------------------------
Protocol
An outline of care; a treatment plan.
Model
Reproduction of structures made by pouring plaster or stone into a mold.
Analysis
A psychology term for processes used to gain understanding of complex emotional or behavioral issues.
SIMILAR TERMS--------------------------------------
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Pneumonectomy
Surgical procedure to remove the entire lung.
Pulmonologist
A specialist physician expert in the treatment of lung disease.
P value (statistics)
The lowest level of significance at which a given null hypothesis can be rejected; that is, the necessary criterion for determining that the result probably did not happen by chance. See statistical significance.
Pairing
A method by which subjects are selected so that two subjects with similar characteristics (for example, weight, smoking habits) are assigned to a set, but one receives Treatment A and the other receives Treatment B.
Patient file
Contains demographic, medical, and treatment information about a patient or subject. It may be paper-based or a mixture of computer and paper records.
Per protocol set
Period effect
Designated period during the course of a trial in which subjects are observed and no treatment is administered.
Pharmacodynamics
The branch of pharmacology that studies reactions between drugs and living structures, including the processes of bodily responses to pharmacological, biochemical, physiological, and therapeutic effects.
Pharmacoeconomics
Branch of economics that applies cost-benefit, cost-effectiveness, cost-minimisation, and cost-utility analyses to compare the economics of different pharmaceutical products or to compare drug therapy to other treatments. Sometimes referred to as outcomes research.
Pharmacogenetics
The study of the way drugs interact with genetic makeup or the genetic response to a drug.
Pharmacokinetics
The study of the processes of bodily absorption, distribution, metabolism, and excretion of compounds and medicines.
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