[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 (i.e., Particle Size) of Oral Inhaled and Nasal Drug Products (ONDPs).
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Course Feedback Survey
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Added 6 days ago, by Geetha
Added 27 days ago, by Angeliki
Very useful and interesting course. Thank you for providing this for free. I think it would also be useful to have the RSABE templates validated. Thank you.
Added 28 days ago, by dario
Added about 1 month ago, by Ahmed
Added 2 months ago, by Patel
Informative and usefull courses
Added 3 months ago, by MARTHA
Added 8 months ago, by Segun
Added 9 months ago, by Anonymous
Added 9 months ago, by Raju
Added 10 months ago, by Wiesia

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