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jag009 ★★★ NJ, 2012-05-22 23:31 (5144 d 05:27 ago) Posting: # 8607 Views: 3,769 |
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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 |
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drgunasakaran1 ★★  2012-05-31 16:34 (5135 d 12:24 ago) @ jag009 Posting: # 8644 Views: 2,901 |
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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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