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Quality by Design: Next Steps to Realize Opportunities? - page 15 / 37

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Appropriate Specification or “Over-discrimination” All Bioequivalent to RLD

DISSOLUTION OF GENERIC & RESEARCH TABLETS

TIME IN MINUTES

0

5

10

15

20

25

30

35

0

10

20

30

40

50

60

70

80

90

100

110

ANDA1

ANDA2

ANDA3

ANDA4

ANDA5

ANDA6

ANDA7

ANDA8

ANDA8

74-217

UMAB-SLOW

UMAB-MEDIUM

UMAB-FAST

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