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jag009 ★★★ NJ, 2012-04-17 23:42 (5187 d 20:19 ago) Posting: # 8437 Views: 3,303 |
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Hi everyone, If a product is labeled as "can be chewed or swallowed as a tablet". The generic BE program should include two SD studies: 1) Test (swallowed) vs Ref (swallowed) 2) Test: Chewed vs Swallowed Correct? Thanks John |
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CLR ☆ Singapore, 2012-04-18 08:29 (5187 d 11:32 ago) @ jag009 Posting: # 8438 Views: 2,816 |
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Hi John, I think an SD study for swallowed dosing will suffice. For example, the FDA's product-specific guidance for montelukast chewable tablets (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm088707.pdf) states that the tablet should be swallowed whole - this would ensure the standardised delivery of the dose, as opposed to variability introduced during chewing. Perhaps other more experienced members of this forum will be able to lend more insight Clare |
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jag009 ★★★ NJ, 2012-04-18 17:21 (5187 d 02:39 ago) @ CLR Posting: # 8441 Views: 2,719 |
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❝ Hi John, ❝ ❝ I think an SD study for swallowed dosing will suffice. For example, the FDA's product-specific guidance for montelukast chewable tablets (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm088707.pdf) states that the tablet should be swallowed whole - this would ensure the standardised delivery of the dose, as opposed to variability introduced during chewing. . Thanks Clare |
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