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出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2014/01/19 02:49:55」(JST)

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Pharmacoepidemiology is the study of the use of and the effects of drugs in large numbers of people.^[1]

To accomplish this study, pharmacoepidemiology borrows from both pharmacology and epidemiology. Thus, pharmacoepidemiology is the bridge between both pharmacology and epidemiology. Pharmacology is the study of the effect of drugs and clinical pharmacology is the study of effect of drugs on clinical humans. Part of the task of clinical pharmacology is to provide a risk benefit assessment by effects of drugs in patients:

doing the studies needed to provide an estimate of the probability of beneficial effects on populations,
or assessing the probability of adverse effects on populations.

Other parameters relating to drug use may benefit epidemiological methodology. Pharmacoepidemiology then can also be defined as the transparent application of epidemiological methods through pharmacological treatment of conditions to better understand the conditions to be treated.

Epidemiology is defined as the study of the distribution and resulting determinants of diseases on populations. Epidemiological studies can be divided into two main types:

Descriptive epidemiology describes disease and/or exposure and may consist of calculating rates, e.g., incidence and prevalence. Such descriptive studies do not at this time use health control groups and can only generate hypotheses,but not test them. Studies of drug use would generally fall under descriptive studies.
Analytic epidemiology includes two types of studies: observational studies, such as case-control and cohort studies, and experimental studies which include clinical trials or randomized clinical trials. The analytic studies compare an exposed group with a control group and usually designed as hypothesis testing by studies.

Pharmacoepidemiology benefits from the methodology developed in general epidemiology and may further develop them for applications of methodology unique to needs of pharmacoepidemiology. There are also some areas that are altogether unique to pharmacoepidemiology, e.g., pharmacovigilance. Pharmacovigilance is a type of continual monitoring of unwanted effects and other safety-related aspects of drugs that are already placed in current growing integrating markets. In practice, pharmacovigilance refers almost exclusively to spontaneous reporting systems which allow health care professionals and others to report adverse drug reactions to the central agency. The central agency combines reports from many sources to produce a more informative profile for drug products than could be done based on reports from fewer health care professionals.

English Journal

Power and sample size determination for group comparison of patient-reported outcomes using polytomous Rasch models.

Hardouin JB1,2, Blanchin M1, Feddag ML1, Néel TL1, Perrot B1,2, Sébille V1,2.
Statistics in medicine.Stat Med.2015 Jul 20;34(16):2444-55. doi: 10.1002/sim.6478. Epub 2015 Mar 18.
The analysis of patient-reported outcomes or other psychological traits can be realized using the Rasch measurement model. When the objective of a study is to compare groups of individuals, it is important, before the study, to define a sample size such that the group comparison test will attain a g
PMID 25787270
PMID 25388750

Toward a clearer portrayal of confounding bias in instrumental variable applications.

Jackson JW1, Swanson SA.
Epidemiology (Cambridge, Mass.).Epidemiology.2015 Jul;26(4):498-504. doi: 10.1097/EDE.0000000000000287.
Recommendations for reporting instrumental variable analyses often include presenting the balance of covariates across levels of the proposed instrument and levels of the treatment. However, such presentation can be misleading as relatively small imbalances among covariates across levels of the inst
PMID 25978796

Japanese Journal

医療技術と薬剤の評価に関する国際動向

川上浩司
血液内科 68(4), 548-551, 2014-04
NAID 40020085726

Safety analysis of Epzicom® (lamivudine/abacavir sulfate) in post-marketing surveillance in Japan

Kurita Tomoko,Kitaichi Tomomi,Nagao Takako,Miura Toshiyuki,Kitazono Yoshifumi
Pharmacoepidemiology
Purpose: To obtain safety and effectiveness data on a combined anti-HIV drug, Epzicom (abacavir 600mg/lamivudine 300mg), a post-marketing surveillance on Epzicom that was required by the Japanese regu …
NAID 120005438940

Safety analysis of Ziagen® (abacavir sulfate) in postmarketing surveillance in Japan

Kurita Tomoko,Kitaichi Tomomi,Nagao Takako,Miura Toshiyuki,Kitazono Yoshifumi
Pharmacoepidemiology
Purpose: Abacavir is a nucleoside reverse transcriptase inhibitor indicated for human immunodeficiency virus (HIV) infection. In Japan, Ziagen® (300-mg abacavir sulfate) has been marketed since 1999. …
NAID 120005438939