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Course details

  • Language

    English

(106-FL) Free Phoenix Templates for Bioequivalence Regulatory Guidances

Cost - Free

Several easy-to-use 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.

Current Available Phoenix Workflow Templates:

  • Assessing Reference Scaled Average Bioequivalence (RSABE) for Highly Variable Drugs (HVD) - FDA + EMA
  • Assessing Reference Scaled Average Bioequivalence (RSABE) for Narrow Therapeutic Index Drugs (NTID) - FDA
  • Assessing Bioequivalence to Methylphenidate Hydrochloride (Concerta) - FDA

 

Training material

  • About this Free Course
  • RSABE for Highly Variable Drugs (HVD)
    • RSABE for Highly Variable Drugs (HVD)
    • RSABE HVD Introduction
    • How to use the FDA RSABE project template with a Full Replicate Design
    • How to use the FDA RSABE project template with a Partial Replicate Design
  • RSABE for Narrow Therapeutic Index Drugs (NTID)
    • Narrow Therapeutic Index Drugs (NTIDs)
    • AAPS 2017 Poster: RSABE Approach For NTID Using Phoenix WinNonlin
  • BE Analysis to Methylphenidate Hydrochloride
    • BE Analysis to Methylphenidate Hydrochloride (Concerta)
    • Introductory Video on BE Analysis to Methlyphenidate Hydrochloride
    • AAPS 2018 Poster
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