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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.
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Thanks Clare
Complete thread:
- BE study design question jag009 2012-04-17 21:42
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE study design question CLR 2012-04-18 06:29
- BE study design questionjag009 2012-04-18 15:21
- BE study design question CLR 2012-04-18 06:29
Ing. Helmut Schütz