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Table. 3.

Table. 3.

Regular safety data evaluation and periodicity for Investigational Product in Pharmaceutical companies

Response Periodicity Domestic N (%) Global N (%)
Yes (n=9, 69.2%) Once in a year (n=5, 38.5%) 1 (7.7) 4 (30.8)
Once in a quarter (n=1, 7.7%) 1 (7.7) 0 (0)
Depends on IP* a (n=3, 23.1%) 1 (7.7) 2 (15.4)
No (n=2, 15.4%) 1 (7.7) 1 (7.7)
Product specificb (n=2, 15.4%) Once in a year (n=1, 7.7%) 1 (7.7) 0 (0)
If necessary (n=1, 7.7%) 1 (7.7) 0 (0)

a The company conducts safety data evaluation regularly for all the Investigational product but the evaluation periodicity is depending on the product.

b Product specific means the company does not conduct safety data evaluation regularly for all the Investigational product but they do for specific product.

* IP: Investigational Product

Korean J Clin Pharm 2021;31:53-60 https://doi.org/10.24304/kjcp.2021.31.1.53
© 2021 Korean J Clin Pharm