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Fig. 6 | Journal of Pharmaceutical Health Care and Sciences

Fig. 6

From: Risk Management Plans: reassessment of safety concerns based on Good Pharmacovigilance Practices Module V (Revision 2)—a company experience

Fig. 6

Reduction of safety concerns by type of safety concern (A), product type and market launch (B), and number of safety concerns (C). A The dark grey bar on the left shows the median % reduction of safety concerns across all 3 categories. The 3 red bars on the right are subsets of the total shown on the left, providing the median % reduction by category of safety concerns (IIR vs. IPR vs. MI). For products that did not include a specific category of safety concerns, the % reduction for this category was imputed as 0. B The 2 lighter gray bars on the left and the 3 red bars on the right are subsets of the total shown in dark grey in Fig. 6A on the left. The 2 lighter gray bars show the median % reduction of safety concerns by product type (small molecule vs. biologic); the 3 red bars show the median % reduction of safety concerns by time on the market. C The red bars are subsets of the total shown in grey in Fig. 6A on the left, providing the median % reduction of safety by the number of safety concerns in the RMP before applying the algorithms. IIR, Important Identified Risk; IPR, Important Potential Risk; MI, Missing Information; n, number of RMPs analyzed; RMPs, Risk Management Plans; Small mol, small molecule; yrs, years

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