Mahmoud ☆ Jordan, 2020-07-03 14:09 (287 d 18:03 ago) Posting: # 21642 Views: 2,042 |
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Dear All ======== in the following SAS code proc mixed data=d1; In the Random statement TYPE=CSH could possibly be replaced by TYPE=FA(1) FA(1) is not the same as FA0(2) Thank You M.Youseed Edit: Category and subject line changed; see also this post #1. [Helmut] |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2020-07-03 14:46 (287 d 17:26 ago) @ Mahmoud Posting: # 21644 Views: 1,655 |
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Hi Mahmoud, » in the following SAS code where does this code come from? It’s not the standard one recommended by the FDA here and there. » model AUCT=sequence period treat/DDFM=kr; I would suggest to use DDFM=SATTER (as the FDA recommends). The default of DDFM=KR uses the observed information matrix (SCORING=0 ) as does JMP. You may run into troubles if your study is re-evaluated in other software which uses the expected information matrix (e.g., Stata, R-package replicateBE ). In SAS you can get the expected information matrix by setting SCORING=1 .» random treat/type=CSH subject=subject G; » » In the Random statement TYPE=CSH could possibly be replaced by TYPE=FA(1) Acc. to the FDA’s guidance, Appendix E: In the Random statement, » FA(1) is not the same as FA0(2) Of course. FA(q ) = factor analytic and FA0(q) = no diagonal factor analytic.If this is a full replicate design, I would follow the FDA’s recommendation and use FA0(2) .However, in the stupid partial replicate designs (TRR|RTR|RRT or TRR|RTR) the optimizer may fail to converge since the model is over-specified (T not repeated). Then you’ve performed a study and don’t get a result cause SAS shows you the finger.* I suggest to specify FA0(1) instead. State that already in the SAP.
— Dif-tor heh smusma 🖖 Helmut Schütz ![]() The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Mahmoud ☆ Jordan, 2020-07-03 16:49 (287 d 15:24 ago) @ Helmut Posting: # 21646 Views: 1,653 |
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Thank you very much The BE study is (TRRT,RTTR) two sequence four period GMR Lower Upper 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 #5! [Helmut] |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2020-07-03 17:00 (287 d 15:12 ago) @ Mahmoud Posting: # 21647 Views: 1,616 |
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Hi Mahmoud, » GMR Lower Upper » when i used FDA code the result for Cmax 85.734 79.363 92.617 » when i used code FDA but type=FA(1) the result is Cmax 85.925 80.087 92.190 Are you trying to “safe” a failed study? What is stated in the SAP? — Dif-tor heh smusma 🖖 Helmut Schütz ![]() The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Mahmoud ☆ Jordan, 2020-07-03 17:17 (287 d 14:55 ago) @ Helmut Posting: # 21648 Views: 1,610 |
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Dear Dr ======= Thank you very much for your information in This study I found that and for Cmax Pk that CVintra =27.3217 and CVinter=20.7271 this is not true in BE studies From most studies CVinter is more more than CVintra I think that the two types=CSH or FA0(1) in the FDA code are not suitable to obtain these results » Are you trying to “safe” a failed study? No 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 #5! [Helmut] |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2020-07-03 17:31 (287 d 14:41 ago) @ Mahmoud Posting: # 21649 Views: 1,603 |
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Hi Mahmoud, » Dear Dr Not a Dr ![]() » in This study I found that and for Cmax Pk that » CVintra =27.3217 and CVinter=20.7271 this is not true in BE studies Truth does not belong to the realm of science. ![]() » From most studies CVinter is more more than CVintra Correct; sometimes CVintra > CVinter. » I think that the two types=CSH or FA0(1) in the FDA code are not suitable to obtain these results Why, can you elaborate? » » Are you trying to “safe” a failed study? » No I see. Please answer my other question (also in the subject line) » » What is stated in the SAP? as well. — Dif-tor heh smusma 🖖 Helmut Schütz ![]() The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |