Validation of Epidemiological Methods for Studying the Infection Risk in Rheumatoid Arthritis with Methotrexate Combined Biologicals using Propensity Scores-Reference-Cited by-同舟云学术

Validation of Epidemiological Methods for Studying the Infection Risk in Rheumatoid Arthritis with Methotrexate Combined Biologicals using Propensity Scores

Published:2021-06-20 Issue:1 Volume:26 Page:27-40
ISSN:1342-0445
Container-title:Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku
language:en
Short-container-title:Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku

Author:

KOINUMA Takuma¹,AKAZAWA Manabu²

Affiliation:

1. Welcia Pharmacy CO, Ltd., Japan

2. Department of Public Health and Epidemiology, Meiji Pharmaceutical University School, Japan

Publisher

Japanese Society for Pharmacoepidemiology

Subject

General Medicine

Link

https://www.jstage.jst.go.jp/article/jjpe/26/1/26_26.e3/_pdf

Reference38 articles.

1. 1) Scientific guidance on post-authorisation efficacy studies - Draft. European Medicines Agency. ［http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/11/WC500196379.pdf (accessed 2019-12-1)]

2. 2) Kesselheim AS, Avorm J. New “21st Century Cures” Legislation： Speed and Ease vs Science. JAMA 2017：317 (6)：581-2. doi： 10.1001/jama.2016.20640.

3. 3) Use of real-world evidence to support regulatory decision-making for medical devices - Draft guidance for industry and Food and Drug Administration staff. FDA CDRH and CBER.［https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm513027.pdf (accessed 2019-12-1)］

4. 4) Suissa S. Immortal time bias in observational studies of drug effects. Pharmacoepidemiol Drug Saf 2007；16（3）： 241-9. doi： 10.1002/pds.1357.

5. 5) Suissa S. Immortal time bias in pharmaco-epidemiology. Am J Epidemiol 2008；167 (4)：492-9. doi： 10.1093/aje/kwm324.