[106-FL] Free Phoenix Templates for Bioequivalence Regulatory Guidances

6 modules



Course Length
8 hours

Ana Henry



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.

Course Content:

  • 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

Template Downloads
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RSABE for Highly Variable Drugs (HVD)
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Narrow Therapeutic Index Drugs (NTIDs)
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BE Analysis to Methylphenidate Hydrochloride
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ABE and PBE for In Vitro Data of Inhaled Products.
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Course Feedback Survey
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Added about 2 months ago, by Lan
Phenix is very useful and the training videos are great.
Added 5 months ago, by Ashutosh
Added 7 months ago, by Malek
Added 10 months ago, by Anonymous
wonderful experience
Added 10 months ago, by Varinder
This course is highly applicable. it gives you an idea about HV/ NID drugs. How different regulatory agencies have defined the limits for BE. Templates for RSABE/ PBE/ABE are very useful.
Added 11 months ago, by Liz Jannet
Added 11 months ago, by Esther
Added 11 months ago, by MARCELO ANGELO SACRAMENTO
Added about 1 year ago, by Rosa
Added about 1 year ago, by Anas

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