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Phaneendra.K ☆ 2011-02-01 17:25 (5627 d 22:56 ago) Posting: # 6529 Views: 3,204 |
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If i want to formulate a new FDC in which one is of a newer molecule .. example.. say for an indication there is an innovator FDC of LISINOPRIL + X. For the same indication if i formulate PERINDOPRIL + X among which Lisinopril and perindopril are of the same category.. do i have to conduct a BE study or a clinical trial.. — Thanks and Regards, PK |
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manan ☆ Ahmedabad, 2011-02-02 10:54 (5627 d 05:28 ago) @ Phaneendra.K Posting: # 6538 Views: 2,617 |
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Dear Phaneendra Of course you need to conduct the trial even if the drugs are from same class. The drug will show different PK characters even having same mechanism or actions. We do BE study for many anti hypertensive drug combinations no matter in same or different class |
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d_labes ★★★ Berlin, Germany, 2011-02-02 12:42 (5627 d 03:40 ago) @ Phaneendra.K Posting: # 6542 Views: 2,675 |
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Dear Phaneendra, I bet, as opposed to manan, for a Clinical Trial. IMHO the combination X + Lisinopril is not generic to X + Perindopril. They contain different active substances and fullfill therefore not the requirements to do a BE study as surrogate for a clinical study or as a study to show the pharmaceutical quality  . Both combinations may have especially different safety profiles due to the different ingredients or due to different interactions to your ominous X drug. The different anti-hypertensive components themselves will lead also to different efficacies of course. Being in the same drug category (here anti-hypertensive) is also not a reason to assume that the PK characteristics are the same (f.i. AUCLisinopril not necessary equal AUCPerindopril). Thus you compare Apples and Oranges if you attempt to do a BE study. — Regards, Detlew |
Ing. Helmut Schütz