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RegisterTruncation (FDA: no HVDs) [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2012-08-14 16:18 (5061 d 22:49 ago) – Posting: # 9061
Views: 4,877
Dear Hiren!
Very good question! I was always wondering myself what is the rationale behind this statement in FDA’s guidance (contrary to EMA’s where truncation is acceptable for all IR products). One could only prove lacking high variability in distribution and clearance (CVintra <30%) by administering a solution (!) twice.
Since this variability is expected to be less than the variability seen after administration of a formulation, maybe reference to literature data or previous studies (where CVintra was <30%) is sufficient as well.
Does anybody have some practical experiences?
P.S.: Do you have an answer to my question at the end of this post?
❝ How to prove that there is no high variability in Distribution and Clearance phase for using truncated AUC approach for USFDA?
Very good question! I was always wondering myself what is the rationale behind this statement in FDA’s guidance (contrary to EMA’s where truncation is acceptable for all IR products). One could only prove lacking high variability in distribution and clearance (CVintra <30%) by administering a solution (!) twice.
Since this variability is expected to be less than the variability seen after administration of a formulation, maybe reference to literature data or previous studies (where CVintra was <30%) is sufficient as well.
Does anybody have some practical experiences?
P.S.: Do you have an answer to my question at the end of this post?
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Truncation hiren379 2012-08-14 12:01
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Truncation (FDA: no HVDs)Helmut 2012-08-14 14:18
- Truncation (FDA: no HVDs) hiren379 2012-08-14 14:54
- CV, not CI Helmut 2012-08-14 15:22
- CV, not CI hiren379 2013-12-13 07:53
- CV, not CI Dr_Dan 2013-12-13 09:49
- CV, not CI hiren379 2013-12-13 07:53
- CV, not CI Helmut 2012-08-14 15:22
- Truncation (FDA: no HVDs) hiren379 2012-08-14 14:54
- Truncation (FDA: no HVDs)Helmut 2012-08-14 14:18
Ing. Helmut Schütz