Complimentary Phoenix Templates for Bioequivalence.
Several easy-to-use Phoenix templates, that require minimum user input, have been developed to address a series of BE regulatory guidances. In this course, we discuss the purpose of each Phoenix workflow template, show you how to download templates, and teach you and how to use them.
- Module 1: Template Downloads
- Module 2: Assessing Reference Scaled Average Bioequivalence (RSABE) for Highly Variable Drugs (HVD) - FDA + EMA
- Module 3: Assessing Reference Scaled Average Bioequivalence (RSABE) for Narrow Therapeutic Index Drugs (NTID) - FDA
- Module 4: Assessing Bioequivalence to Methylphenidate Hydrochloride (Concerta) - FDA
- Module 5: Assessing ABE and PBE for In Vitro Data of Inhaled Products (Guidance on Budesonide) - FDA
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