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BRN ☆ Turkey, 2015-07-15 12:21 (3531 d 00:36 ago) (edited on 2015-07-15 16:44) Posting: # 15086 Views: 6,080 |
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Dear All, We have a BE study for a fixed dose combination (FDC) product (T) which does not have an original reference. So our reference product (R) becomes administration of R1 and R2 in combination (R=R1+R2). However in other periods these original products are administered as monotherapy as per local regulations. The protocol mentions the BE conclusion will be based on T vs. R. Now my question is, what's the best approach for the statistical analysis?
From my point of view the best approach will be the first option but I'd like to hear some expert comments. Is there any other options, suggestions? Thank you in advance for your kind support. — Regards, BRN |
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jag009 ★★★ NJ, 2015-07-16 08:22 (3530 d 04:35 ago) @ BRN Posting: # 15090 Views: 4,893 |
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Hi, I don't understand your reasons for #2 and #3. You said the test is a FDC and there is no reference FDC. Therefore your reference would be to administer 2 products (R1 and R2).. #1 will work. I ran this kind of study for an NDA FDC before and there were no issues. Thanks John |
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BRN ☆ Turkey, 2015-07-16 13:23 (3529 d 23:33 ago) @ jag009 Posting: # 15094 Views: 4,810 |
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Hi John, thank you for your reply. ❝ I don't understand your reasons for #2 and #3. Actually the study is a 4 period study. The aim is to compare T and R in terms of BE, additionally to investigate drug interactions at the same time since there is no FDC as reference. That's why investigating the BE as 2 period study makes sence to me as well, however I've seen examples such as #2 and #3, that's why trying to make sure which is the best approach. — Regards, BRN |
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Dr_Dan ★★ Germany, 2015-07-16 11:12 (3530 d 01:44 ago) @ BRN Posting: # 15092 Views: 4,852 |
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Dear BRN, As you explained you have a fixed dose combination (FDC) product which does not have an original reference. So bioequivalence with the reference products R1 and R2 in combination (R=R1+R2) is only one aspect. The other question you Need to answer is: How do you know that this combination is reasonable from a PK point of view? Therefore you have to conduct additionally a drug-drug-interaction (DDI)study. BE: single dose 2x2 design T vs. R1+R2 DDI: multiple dose R1, R2, R1+R2 I hope this helps. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz