Mithu ☆ India, 20200709 09:18 (468 d 14:45 ago) Posting: # 21659 Views: 2,937 

Dear All, Hope all are doing well in such pandemic condition. Today my question is, how to calculate ratio of fully replicate study in excel? I have prepared one excel sheet in which i have put formula to calculate Partial AUC and AUC0t. I am getting correct PK for CMax & AUC's in line with SAS out put but when i am calculating Ratio, it is not matching with SAS out put. Process followed to calculate ratio in excel is as follows: 1. from two T and two R taking average and then taking ratio of T /R. 2. Other case, i had also converted average of both T & R in LN and then taken ratio of LN T & LN R. In both of the cases, i could not get ratio as per SAS. Does SAS has some other formula to calculate ratio? Please help and educate me to calculate correct ratio of fully replicate study in line with SAS out put. Please stay safe. Regards, Mithu Edit: Category changed. [Helmut] 
Helmut ★★★ Vienna, Austria, 20200709 10:51 (468 d 13:12 ago) @ Mithu Posting: # 21660 Views: 2,480 

Hi Mithu, » […] how to calculate ratio of fully replicate study in excel? » I have prepared one excel sheet in which i have put formula to calculate Partial AUC and AUC0t. » I am getting correct PK for CMax & AUC's in line with SAS out put but when i am calculating Ratio, it is not matching with SAS out put. Without knowing your SAS code it would be reading tea leaves. Why on earth do you want to use Excel? » Process followed to calculate ratio in excel is as follows: » 1. from two T and two R taking average and then taking ratio of T /R. » 2. Other case, i had also converted average of both T & R in LN and then taken ratio of LN T & LN R. $$x/y=\exp (\log_{e}x\log_{e}y)\;\left\{x,y \in \mathbb{R}^{+} \right\}\; {\color{red}{\neq}}\log_{e}x/\log_{e}y$$ — Diftor heh smusma 🖖 Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes 
Mithu ☆ India, 20200709 11:23 (468 d 12:40 ago) @ Helmut Posting: # 21661 Views: 2,474 

Hello Sir, » Without knowing your SAS code it would be reading tea leaves. Why on earth do you want to use Excel? We have used Progesterone program. » $$x/y=\exp (\log_{e}x\log_{e}y)\;\left\{x,y \in \mathbb{R}^{+} \right\}\; {\color{red}{\neq}}\log_{e}x/\log_{e}y$$ Still I could not understand. please. Regards, Mithu 
Helmut ★★★ Vienna, Austria, 20200709 12:19 (468 d 11:44 ago) @ Mithu Posting: # 21662 Views: 2,466 

Hi Mithu, » » Without knowing your SAS code it would be reading tea leaves. » » We have used Progesterone program. … which nowhere gives the subject’s T/Rratios. » » $$x/y=\exp (\log_{e}x\log_{e}y)\;\left\{x,y \in \mathbb{R}^{+} \right\}\; {\color{red}{\neq}}\log_{e}x/\log_{e}y$$ » Still I could not understand. Calculating the ratio of logs (2. of your OP) is nonsense. The individual averaged logdifferences \(I_{ij}\) (for subject \(i\) in sequence \(j\)) are computed in the FDA’s SAS macro by
Let’s have a look at the EMA’s full replicate reference data set:
Which leaves my second question open: » » Why on earth do you want to use Excel? — Diftor heh smusma 🖖 Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes 
Mithu ☆ India, 20200709 12:46 (468 d 11:17 ago) @ Helmut Posting: # 21663 Views: 2,438 

Hello Sir, » Then$$\overline{I_{11}}=0.5\times(7.578565+7.9572617.7345417.204848)=0.2982185$$and$$\overline{T_{11}/R_{11}}=\exp \overline{I_{11}}=\exp 0.2982185=1.347456$$ Thank you Sir, now i understand. » Which leaves my second question open: » » » » Why on earth do you want to use Excel? Actually sir when we receive PK data from site (CRO), we check by using Excel. That's why i was using Excel for verification. Generally in average BE and partial replicate, we get it verified but for fully replicate study, i could not match the ratio. This is the story. thank you for your kind guidance and help. regards, Mithu 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, 20200709 13:10 (468 d 10:53 ago) @ Mithu Posting: # 21664 Views: 2,418 

Hi Mithu, » Actually sir when we receive PK data from site (CRO), we check by using Excel. That's why i was using Excel for verification. Generally in average BE and partial replicate, we get it verified but for fully replicate study, i could not match the ratio. » » This is the story. I don’t understand the purpose of this ‘verification’. Calculate the study in SAS. The individual T/Rratios don’t play any role in RSABE (logdifferences are only an intermediate result). Are you concerned about extreme values? They are common for HVD(P)s.^{ 1} Contrary to ABEL (used in all jurisdictions for referencescaling except in the US and China) assessing ‘outliers’^{ 2} is not acceptable for RSABE.
— Diftor heh smusma 🖖 Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes 
Mithu ☆ India, 20200709 13:22 (468 d 10:41 ago) @ Helmut Posting: # 21665 Views: 2,421 

Dear Sir, » I don’t understand the purpose of this ‘verification’. Calculate the study in SAS. The individual T/Rratios don’t play any role in RSABE (logdifferences are only an intermediate result). » Are you concerned about extreme values? They are common for HVD(P)s. Contrary to ABEL (used in all jurisdictions for referencescaling except in the US and China) assessing ‘outliers’ is not acceptable for RSABE. Actually Sir, we do not have SAS at our end (sponsor) but now i got the point that such verification will not help in excel. Actually at present i prepared excel for one of the our HVD and just learning how the data are interpreted. Now i suggest my management to equipped us with proper tool to verify data correctly at our end. CRO runs on SAS and providing PK sheet of data in excel to us and i was checking with excel. But today i got the correct way and understand how the software calculate ratio. Regards, Mithu. 
Helmut ★★★ Vienna, Austria, 20200709 13:56 (468 d 10:07 ago) @ Mithu Posting: # 21666 Views: 2,421 

Dear Mithu, » Actually at present i prepared excel for one of the our HVD and just learning how the data are interpreted. I have strong doubts that is possible to set up the FDA’s mixedeffects model for ABE in Excel. I would never ever rely on its Solver Addin. » CRO runs on SAS … » Now i suggest my management to equipped us with proper tool to verify data correctly at our end. Trust, but verify. (Russian proverb) You would need SAS, JMP, or Phoenix WinNonlin (maybe SPSS, Stata, STATISTICA). Don’t know which one is the least expensive. Only for SAS and Phoenix WinNonlin free code is available. For the others you are on your own. BTW, why are you regularly ignoring some of my questions? Still open: » » Are you concerned about extreme values? They are common for HVD(P)s. Contrary to ABEL (used in all jurisdictions for referencescaling except in the US and China) assessing ‘outliers’ is not acceptable for RSABE. What will you do (or have done in the past) with your ‘verification’? The T/Rratios are not part of the RSABE SASoutput provided by the CRO. — Diftor heh smusma 🖖 Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes 
jag009 ★★★ NJ, 20200709 18:01 (468 d 06:02 ago) @ Helmut Posting: # 21667 Views: 2,387 

Hi Helmut, Sticking my nose in... » I have strong doubts that is possible to set up the FDA’s mixedeffects model for ABE in Excel. I would never ever rely on its Solver Addin. No. Stay away from doing that... I've tried before (just to waste time in the office). » What will you do (or have done in the past) with your ‘verification’? The T/Rratios are not part of the RSABE SASoutput provided by the CRO. I think he might be doing topline prelim analysis for his management team. You know, fresh off the oven? Unfortunately he doesn't have the necessary tools so he's stuck w Excel... I wouldn't verify what the CRO produces unless I have a glance at their SOPs and SAS codes. I mean I would verify but the CRO results are usually the final ones. J 
Mithu ☆ India, 20200710 08:00 (467 d 16:03 ago) @ Helmut Posting: # 21668 Views: 2,354 

Dear Sir, » » » Are you concerned about extreme values? They are common for HVD(P)s. Contrary to ABEL (used in all jurisdictions for referencescaling except in the US and China) assessing ‘outliers’ is not acceptable for RSABE. » » What will you do (or have done in the past) with your ‘verification’? The T/Rratios are not part of the RSABE SASoutput provided by the CRO. First of all please accept my apology. My intention is not to ignoring your question. Actually i do not have any answer for it. I do understand that ratio is not only part of SABE study passout. but this is the only tool which i could work out in excel. for 95% upper bound, i don't have any idea or knowledge to check in excel. Even i could also not able to calculate associate variability i.e. swr in tool like excel. Learning form internet how to calculate PK and putting some efforts at my end. I am learning statistics and when stuck rely on this forum for answer. Again i am sorry if you still fell that i am ignoring your questions. Regards, Mithu. 