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RegisterBE study design question [Design Issues]
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
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
Complete thread:
- BE study design question jag009 2012-04-17 21:42 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE study design questionCLR 2012-04-18 06:29
- BE study design question jag009 2012-04-18 15:21
- BE study design questionCLR 2012-04-18 06:29
Ing. Helmut Schütz