Phaneendra.K
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2011-05-11 11:02
(5519 d 17:24 ago)

Posting: # 7002
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 Usage of multiple units of the dosage form [Design Issues]

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Hi,
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.
Is this given in any guideline?
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Thanks and Regards,

PK
 
Helmut
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2011-05-11 13:31
(5519 d 14:55 ago)

@ Phaneendra.K
Posting: # 7006
Views: 2,670
 

 Usage of multiple units of the dosage form

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Dear Phani!

❝ 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?
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