Log in
Register|
jag009 ★★★ NJ, 2024-07-17 22:29 (144 d 19:46 ago) Posting: # 24080 Views: 2,075 |
|
|
Hi everyone, A dumb question... Does anyone know if Brazil or Mexico accepts bioequivalence study with statistics based on Proc GLM or Proc Mixed? Thx J Edit: Category changed and subject line changed. [Helmut] |
|
Helmut ★★★   Vienna, Austria, 2024-07-18 11:01 (144 d 07:14 ago) @ jag009 Posting: # 24081 Views: 1,719 |
|
|
Hi John, ❝ Does anyone know if Brazil or Mexico accepts bioequivalence study with statistics based on Proc GLM or Proc Mixed? Not knowing, only guessing…
— 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 |
|
Ohlbe ★★★ France, 2024-07-18 11:40 (144 d 06:34 ago) @ Helmut Posting: # 24082 Views: 1,656 |
|
|
Dear John and Helmut, ❝ Mexico accepts widening the limits in case of high with-subject variability. No details about the statistical method (also about ABE) are given in the guideline of 2013.5 No idea whether a more recent guideline exists. I found one from January 2023. Refers to RSABE in the text, to the EMA guideline in the bibliography. — Regards Ohlbe |
|
Helmut ★★★ Vienna, Austria, 2024-07-18 12:42 (144 d 05:33 ago) @ Ohlbe Posting: # 24083 Views: 1,653 |
|
|
Dear Ohlbe, ❝ I found one from January 2023. Refers to RSABE in the text, to the EMA guideline in the bibliography. THX for this goody! Following the bullet points of Section 4), RSABE in this context is a misnomer. It should be SABE. RSABE* (preferred by the US FDA and China’s CDE) is one approach and ABEL another. See also this article. @John: Since the references of the guideline are the EMA’s (in the previous post #2 and #4), an ANOVA (Proc GML). Scaling only for Cmax if \(\small{CV_\text{wR}>30\%}\), upper cap of scaling at \(\small{CV_\text{wR}=50\%}\) (maximum expansion 69.84 – 143.19%), point estimate constraint 80.00 – 125.00%. Likely an ANOVA also for ABE.
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
|
NK ☆ India, 2024-07-19 09:30 (143 d 08:45 ago) @ Helmut Posting: # 24084 Views: 1,623 |
|
|
Dear HS, ❝ * Why the FDA recommends Proc Mixed for partial replicate designs and Proc GLM for full replicate designs is beyond me. For ABE Proc Mixed is recommended for any design. corrected statement FDA recommends Proc GLM for partial replicate designs and Proc MIXED for full replicate designs. Regards NK |
|
Helmut ★★★ Vienna, Austria, 2024-07-19 11:26 (143 d 06:48 ago) @ NK Posting: # 24085 Views: 1,566 |
|
|
Hi NK, ❝ FDA recommends Proc GLM for partial replicate designs and Proc MIXED for full replicate designs. THX, you are right. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
|
jag009 ★★★ NJ, 2024-07-23 21:43 (138 d 20:31 ago) @ Helmut Posting: # 24093 Views: 1,432 |
|
|
Thank you all! J |
Ing. Helmut Schütz