[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 of Inhaled Products.
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6.
Course Feedback Survey
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Added 5 days 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 17 days ago, by Liz Jannet
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Added 24 days ago, by Esther
 
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