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RSABE Templates for Phoenix WinNonlin 6.3


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#1 Ana Henry

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Posted 15 November 2013 - 05:38 PM

Workflow templates to do reference-scaled average bioequivalence (RSABE) have been developed in Phoenix WinNonlin 6.3. These templates are available for download at

s3.amazonaws.com/Certara-Presentations/2.../AAPS_2013_RSABE.zip

A free webinar is scheduled for December 3rd, at 11EST to demonstrate how to use these templates. Please register below:


certara.webex.com/certara/onstage/g.php?d=929560162&t=a

Webinar Description:
Traditional average bioequivalence (ABE) methodology requires prohibitively large sample sizes when used with highly variable drugs and drug products (HVDs/HVDPs), which are defined as products with intra-subject CV% of the reference greater than 30%. This increases the expense of BE studies, places more study subjects at risk, and ultimately limits the availability of generics. Reference-scaled average bioequivalence (RSABE) methodology is increasingly used to demonstrate bioequivalence for HVDs/HVDPs.

Specifics of RSABE methodology vary between regulatory agencies, but both the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) require that subjects receive the reference drug more than once, e.g., replicated 3-period (RRT/RTR/TRR) or 4-period (RTRT/TRTR) crossover designs, so that the BE analysis accounts for within-subject variability.

The Phoenix WinNonlin software provides a BE module to perform average bioequivalence but this module is not currently designed for a complete RSABE analysis. However, RSABE can be performed in Phoenix WinNonlin 6.3 using reusable template projects and workflows for both EMA and FDA approaches. These template projects require minimal input from the user in order to be used with any input dataset from a replicated 3-period or 4-period crossover design. These Phoenix template projects are available for free download and the objective of this webinar is to demonstrate how they work.


Edited by Simon Davis, 27 October 2014 - 01:59 PM.


#2 Simon Davis

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Posted 04 September 2017 - 03:27 PM

This webinar is now best viewed on Youtube;
http://https://www.y...h?v=s6G-16jYffA
Simon.



And for more recent versions of the templates please follow these threads;

https://support.cert...e-ema’s-abel/
and
https://support.cert...ix-14/?hl=rsabe

Edited by Simon Davis, 06 September 2017 - 06:05 AM.


#3 mittyright

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Posted 04 September 2017 - 03:42 PM

Hi Simon,

 

are you planning a new one with improved version of templates? many things are changed there

Maybe Helmut can join the party  ;)

 

Mittyright



#4 Simon Davis

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Posted 24 September 2018 - 08:10 AM

Tomorrow, (25th Sept 2018) there is a free Webinar:  Learn how reference-scaled average bioequivalence (RSABE) templates can save time and increase users’ productivity. Register here: http://bit.ly/2nSFjsl

 

  Simon.






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