jag009
★★★

NJ,
2012-05-22 23:31
(5149 d 22:55 ago)

Posting: # 8607
Views: 3,796
 

 Adderall [Bioanalytics]

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Hi Everyone,

As per FDA, BE studies for Mixed Amphetamine (Adderall, Adderall XR) requires measurement of both D- and L-amphetamine in the plasma. What about the requirement of 5% difference in relative potency (total Assay) between test and reference product? Does one have to demonstrate that on both D and L forms of amphetamine?

Thanks

John
 
drgunasakaran1
★★  
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2012-05-31 16:34
(5141 d 05:52 ago)

@ jag009
Posting: # 8644
Views: 2,912
 

 Adderall

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Dear Mr John,
The requirement of 5% difference in relative potency will be applicable for both D- and L-amphetamine.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
 
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