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

Content
6 modules

Difficulty
Intermediate

Rating

Course Length
8 hours

Instructor
Ana Henry

Price
Free

Description

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

1.
Template Downloads
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2.
RSABE for Highly Variable Drugs (HVD)
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3.
Narrow Therapeutic Index Drugs (NTIDs)
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4.
BE Analysis to Methylphenidate Hydrochloride
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5.
ABE and PBE for In Vitro Data (i.e., Particle Size) of Oral Inhaled and Nasal Drug Products (ONDPs).
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6.
Course Feedback Survey
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Added 6 days ago, by Nikhil
 
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Added 8 months ago, by Katherine
 
Added 8 months ago, by Cinzia
 
Added 8 months ago, by Geetha
 
Added 9 months 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 9 months ago, by dario
 
Added 10 months ago, by Ahmed
 
Added 10 months ago, by Patel
Informative and usefull courses

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