New templates from the BEWGG

Submitted by c.angulo on Thu, 02/07/2019 - 16:15
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To complement the template developed by the BEWGG for Biopharmaceutics Classification System (BCS) Biowaivers Assessment Reports, a template for Biowaiver Assessment Report for Additional Strength(s) of Systemically Active Immediate Release Oral Dosage Forms was developed for use by IPRP Members. The Members of the Working Group envisage that this template will also be of benefit to applicants and the broader regulatory community and have decided to make the Biowaiver Assessment Report for Additional Strength(s) of Systemically Active Immediate Release Oral Dosage Forms available on the IPRP website on the BEWGG page.