I realized that I didn’t make these templates available to the forum members even if the information was sent to attendees of the original webinar on RSABE templates.
If you are interested, we have updated the RSABE (reference-scaled average bioequivalence) templates to work with Phoenix 1.4 (Phoenix WinNonlin 6.4). These templates follow the FDA and EMA guidances included as part of the documents within the project. Please read the instructions (documents/instructions) before using these templates. Be advised that these templates were developed as part of an AAPS poster and have been tested by the authors but have not followed a Pharsight development process.
Tomorrow, (25th Sept 2018) there is a free Webinar using the latest version of Phoenix: Learn how reference-scaled average bioequivalence (RSABE) templates can save time and increase users’ productivity. Register here: http://bit.ly/2nSFjsl
Simon.
The focus of the session was RSABE for NTID (narrow therapeutic index drugs).
You can register for free (and with a non-business email) at Certara University where you can download all the available templates by following the link below. For highly variable drugs, FDA RSABE for 3-period full-replicate design is included. However, the narrow therapeutic drug templates are only for 4-period full design.
You can register for free (and with a non-business email) at Certara University where you can download all the available templates by following the link below. For highly variable drugs, FDA RSABE for 3-period full-replicate design is included. However, the narrow therapeutic drug templates are only for 4-period full design.
[/quote]Dear Ana,
I read this statement from the instruction document provided in FDA RSABE template:
“For Full replicate designs the only design accepted is a 4-period with sequences TRTR and RTRT where R=reference and T=Test. No other designs are accepted”.
So I want to reconfirm it again. Does FDA accepted a RTR/TRT design? Please help me on this!
Thanks so much,
Gigi
So I would be inclined to lean that way but I’m not a statistician so I can’t confirm their rationale. Perhaps you would be best contacting them directly yourself for your compound if you can’t find a specific guidance. Or you could see if anyone on the BEBAC forum has asked a similar question; e.g. http://forum.bebac.at/forum_entry.php?id=16315.
Where did you read this? Section 5.e. states: “NTID’s can only be analyzed with a full replicate design (4-period TRTR | RTRT). The template is set up to only work with this type of study design.”
Can I analyze full-replicate (3-period-RTR/TRT) design with RSABE template according to FDA guidance, and how to do it.
With some ambition, yes. Personally I think that 3-period full replicate designs (TRT | RTR or TRR | RTT) should do the job as well. Now for the (big!) but: The FDA’s guidance specifically recommends a four-period full replicate design. I would not deviate from this recommendation without a controlled correspondence. Otherwise, you risk an RtR. I can imagine that the FDA will not accept such a design because s ²wT and s ²wR are estimated in different subjects. No problems with scaling and the CI but the comparison of variances is tricky.