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Norah ★ Tunisia, 2018-04-02 14:29 (2209 d 20:23 ago) Posting: # 18630 Views: 2,604 |
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Hello I need your advice please regarding this : if ever a drug combination (like candesartan hydrochlorothiazide) has demonstrated its BE with the princeps, is it mandatory to perform study for candasertan alone (same pharmaceutical company, same dosage) Thanks ! |
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Beholder ★ Russia, 2018-04-09 11:04 (2202 d 23:49 ago) @ Norah Posting: # 18655 Views: 1,806 |
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Hi, Norah! ❝ (same pharmaceutical company, same dosage) What about excipients? The same quality and quantity? — Best regards Beholder |
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Norah ★ Tunisia, 2018-04-10 17:26 (2201 d 17:26 ago) @ Beholder Posting: # 18661 Views: 1,768 |
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Hello Beholder Yes all is the same |
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balakotu ★ India, 2018-04-13 08:40 (2199 d 02:13 ago) (edited by Ohlbe on 2018-04-13 10:22) @ Norah Posting: # 18675 Views: 1,708 |
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Hello Norah, As per USFDA, it is mandatory to perform separate studies for separate products. FDA will not accept plain candesartan ANDA without BE studies. Moreover, candesartan a BCS class II product and waiver approach (based on combination product BE study) is not possible to get the waiver for plain Candesartan. Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
Ing. Helmut Schütz