Pharmacoepidemiology Book

	Contributors
	Preface to First Edition
	Preface to Second Edition
	Acknowledgements
1	What is Pharmacoepidemiology?	3
2	Study Designs Available for Pharmacoepidemiology Studies	15
3	Sample Size Considerations for Pharmacoepidemiology Studies	29
4	Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiology Studies	39
5	When Should One Perform Pharmacoepidemiology Studies?	57
6	A Public Health Perspective from Academia	69
7	A View from Industry	73
8	A View from a Regulatory Agency	87
9	Pharmacoepidemiology: A View from the US Courtroom	99
10	The Spontaneous Reporting System in the United States	125
11	Spontaneous Reporting Systems Outside the United States	139
12	Intensive Hospital-based Cohort Studies	157
13	Group Health Cooperative of Puget Sound	171
14	Kaiser Permanente Medical Care Program: Northern California and Other Regions	187
15	Medicaid Databases	199
16	Health Databases in Saskatchewan	217
17	Automated Record Linkage and Other Approaches to Pharmacoepidemiology in The Netherlands	231
18	The Tayside Medicines Monitoring Unit (MEMO)	245
19	Inpatient Databases	257
20	Harvard Community Health Plan	277
21	Clinical Pharmacy Drug Surveillance Network	289
22	Case-Control Surveillance	301
23	Other Approaches to Pharmacoepidemiology Studies	323
24	How Should One Perform Pharmacoepidemiology Studies? Choosing Among the Available Alternatives	337
25	Premarketing Applications of Pharmacoepidemiology	353
26	Determining Causation from Case Reports	365
27	Studies of Drug Utilization	379
28	Evaluating and Improving Physician Prescribing	395
29	The Role of Therapeutic Drug Monitoring in Pharmacoepidemiology	413
30	Screening for Unknown Effects of Newly Marketed Drugs	431
31	The Use of Pharmacoepidemiology to Study Beneficial Drug Effects	449
32	Pharmacoeconomics: Economic Evaluation of Pharmaceuticals	469
33	Using Quality-of-Life Measurements in Pharmacoepidemiology Research	495
34	N-of-1 Randomized Clinical Trials in Pharmacoepidemiology	507
35	The Use of Meta-analysis in Pharmacoepidemiology	525
36	Validity of Pharmacoepidemiology Drug and Diagnosis Data	549
37	Special Methodological Issues in Pharmacoepidemiology Studies of Vaccine Safety	581
38	Special Considerations in Studies of Drug-induced Birth Defects	595
39	Bias and Confounding in Pharmacoepidemiology	609
40	Novel Approaches to Pharmacoepidemiology Study Design and Statistical Analysis	629
41	The Future of Pharmacoepidemiology	649
	Appendix A - Sample Size Tables	659
	Appendix B - Glossary	693
	Index	701