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RegisterUsage of multiple units of the dosage form [Design Issues]
posted by Helmut 
– Vienna, Austria, 2011-05-11 13:31 (5524 d 05:12 ago) – Posting: # 7006
Views: 2,672
Dear Phani!
If the RLD is 300 mg, FDA wants you to perform the study with exactly this strength. Which “reason they weren't available” are you thinking of?
❝ If the RLD drug has a strength of 300 mg, and for some reason they weren't available, then, for conducting a BE study of the test 300 mg tablets, can two units of the reference, each of 150 mg tablets, be used.
If the RLD is 300 mg, FDA wants you to perform the study with exactly this strength. Which “reason they weren't available” are you thinking of?
—
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. 🚮
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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:
- Usage of multiple units of the dosage form Phaneendra.K 2011-05-11 09:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Usage of multiple units of the dosage formHelmut 2011-05-11 11:31
Ing. Helmut Schütz