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Ramesh Ramalingam ☆ India, 2018-06-18 10:00 (2132 d 08:04 ago) Posting: # 18913 Views: 3,845 |
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Dear All, As per guidelines, Subjects with non-zero baseline concentrations > 5% of Cmax. Such data should be excluded from bioequivalence calculation. Is it applicable for endogenous molecule? could you please suggest anyone.. Regards, Ramesh. R |
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Helmut ★★★   Vienna, Austria, 2018-06-18 12:59 (2132 d 05:05 ago) @ Ramesh Ramalingam Posting: # 18914 Views: 3,296 |
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Hi Ramesh, ❝ As per guidelines, Subjects with non-zero baseline concentrations > 5% of Cmax. Such data should be excluded from bioequivalence calculation. ❝ Is it applicable for endogenous molecule? All your posts are in the category Regulatives / Guidelines. Remember that our job is not exegesis but science. Hence, what do you think? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Ramesh Ramalingam ☆ India, 2018-08-08 09:29 (2081 d 08:35 ago) @ Helmut Posting: # 19159 Views: 2,994 |
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Dear Helmut, As per previous discussion. We can't directly assess the carry-over effect for endogenous substances. As per USFDA regulatory requirement we have to approach the concept of 5% cmax for endogenous substances also https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM234960.pdf. but they are not clearly telling about how to approach these concept for endogenous substances. Kindly share your suggestions about to below statements. When dealing with endogenous substances, the presence of carry-over effects is very difficult to quantify. Therefore to find a proof of absence or presence of carryover effect in endogenous substances, the pre-dose (baseline) drug concentrations for Period 1 should compared to the pre-dose concentrations for Period 2. Thus, previous period average pre-dose concentration should be subtracted with subsequent period average pre-dose concentration after that the resulted values should compare with 5% of cmax. Based on this we can ensure the carry over effect occurred or not in period 1 or in subsequent period. Regards, Ramesh.R |
Ing. Helmut Schütz