Characteristics of Post-Marketing Studies and their Contribution to Post-Marketing Safety Measures in Japan

Author:

Kanmuri Kazuhiro,Narukawa Mamoru

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference15 articles.

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2. Rogers AS. Adverse drug events: identification and attribution. Drug Intell Clin Pharm. 1987;21:915–20.

3. WHO Policy Perspectives on Medicines. Pharmacovigilance: ensuring the safe use of medicines—WHO Policy Perspectives on Medicines, No. 009, October 2004. http://apps.who.int/medicinedocs/pdf/s6164e/s6164e.pdf . Accessed 18 Oct 2013.

4. Directors of Safety Division Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare [MHLW] and Director of Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW. Risk management plan guidance. http://www.pmda.go.jp/english/service/pdf/mhlw/PFSB-SD-0411-1_PFSB-ELD-0411-1.pdf . Accessed 18 Oct 2013.

5. Yoshioka K, Kosasayama A, Yoshida M, et al. Post marketing surveillance of 13 products: safety and effectiveness. Pharmacoepidemiol Drug Saf. 1999;8:31–43.

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