Bioequivalence and Bioavailability Forum

Maryam ☆ Iran, 2017-01-13 17:28 (2652 d 07:37 ago) Posting: # 16946 Views: 10,650	SAS [Software] Post reply
	HI I want to run this procedure in sas9.1: `proc ttest data=auc dist=lognormal tost(0.8, 1.25); paired TestAUC*RefAUC; run;` but it had an error: How should I solve this problem? thanks

Mahmoud ★ Jordan, 2017-01-15 09:56 (2650 d 15:09 ago) @ Maryam Posting: # 16947 Views: 9,483	SAS Post reply
	Dear Sir For BE studies do not use the t-test paired data.if you need any results in BE study please send me your data in the following email mahmohsen111yahoo.com 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! I activated the e-mail link in your profile. [Helmut]

Helmut
★★★

Vienna, Austria,
2017-01-15 13:16
(2650 d 11:49 ago)

@ Mahmoud
Posting: # 16948
Views: 9,561

Paired vs. crossover

Post reply

Salam Mahmoud,

❝ Dear Sir

I assume that Maryam is not a Sir. ;-)

❝ For BE studies do not use the t-test paired data.

We don’t know the design of Maryam’s study. What if it was not a crossover? Examples where a paired t-test would be correct indeed:

Assessment of linear PK. Single dose followed by steady state and AUC_0–τ vs. AUC_0–∞.
4-period food-effect design where periods 1&2 fed and periods 3&4 fasting. Crossover in fed and fasting state but assessment of the food effect of T and R by a paired t-test (assuming no period effects).

@Maryam: What is the structure of you data? I don’t speak SAS but which error did you get?

—
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

Maryam
☆

Iran,
2017-01-15 17:44
(2650 d 07:20 ago)

@ Helmut
Posting: # 16951
Views: 9,304

Paired vs. crossover

Post reply

❝ We don’t know the design of Maryam’s study.

❝ @Maryam: What is the structure of you data? I don’t speak SAS but which error did you get?

Hi sir
Maryam is not a sir :ok:

thanks for your answer,
my structure is a crossover study! actually I want to calculate 90% CI for BE parameters of test/reference! and I want to evaluate the effect of period, sequence, subject and treatment!

I know how calculate these by formulations but I need a software to calculate these! would you please to guide me in this problem?

thanks

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]

DavidManteigas
★

Portugal,
2017-01-17 16:35
(2648 d 08:30 ago)

@ Maryam
Posting: # 16967
Views: 9,259

Paired vs. crossover

Post reply

@Maryam

For a 2x2 cross-over, the following code will get you everything you need (ods outputs LSMeandiffCL, LSMeans, AltErrTests and OverallANOVA)

proc glm data=replicate;

class formulation subject period sequence;

model logDATA= sequence subject (sequence) period formulation;

estimate "test-ref" formulation -1+1;

test h=sequence e=subject(sequence);

lsmeans formulation / adjust=t pdiff=control("R") CL alpha=0.10;

run;

Formulation and Period p values come from OverallAnova, while sequence p value from AltErrTests.

This code in principle will fit both EMA and FDA requirements for a 2x2 design. Although FDA requests subject within sequence as random effect, this will not change the result.

Helmut
★★★

Vienna, Austria,
2017-01-18 13:57
(2647 d 11:08 ago)

@ DavidManteigas
Posting: # 16972
Views: 9,004

Picky

Post reply

Hi David,

❝ proc glm data=replicate;

Why are you calling a data set of a 2×2 crossover replicate? Of course you can baptize it as you like but “replicate” might confuse newbies.

</nitpicking>

❝ lsmeans formulation / adjust=t pdiff=control("R") CL alpha=0.10;

I would remove adjust=t. There is nothing to adjust in a 2×2 crossover. See this thread.

—
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

DavidManteigas ★ Portugal, 2017-01-27 16:03 (2638 d 09:02 ago) @ Helmut Posting: # 16996 Views: 8,369	Picky Post reply
	Hi Helmut, The reason for "Replicate" as the dataset name is because I took the code from the EMA Q&A Guideline and adapted it - but forgot to remove the misleading name I agree with you regarding the adjusment question. Nevertheless, as far as I understand the parameter does nothing if you leave it on the code.

Maryam
☆

Iran,
2017-01-15 17:31
(2650 d 07:34 ago)

@ Mahmoud
Posting: # 16950
Views: 9,361

SAS

Post reply

❝ For BE studies do not use the t-test paired data.

Hi sir
thanks for your answer.
your are right! t-test paired does not use for BE studies. By SAS and ttest I want to calculate 90% CI for pharmacokinetics parameters of test/reference.
would you please to help me to calculate 90% CI for pharmacokinetics parameters of test/reference by any softwares? can I use this calculation by SPSS?

thanks

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]

Mahmoud ★ Jordan, 2017-01-15 15:36 (2650 d 09:29 ago) @ Maryam Posting: # 16949 Views: 9,328	SAS Post reply
	❝ I want to run this procedure in sas9.1: ❝ ❝ `proc ttest data=auc dist=lognormal tost(0.8, 1.25);` ❝ `paired TestAUC*RefAUC;` ❝ `run;` Dear all ===== For the codes above you need to use SAS 9.3 Mahmoud Ph.D 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]

Maryam ☆ Iran, 2017-01-15 17:50 (2650 d 07:15 ago) @ Mahmoud Posting: # 16952 Views: 9,305	SAS Post reply
	❝ For the codes above you need to use SAS 9.3 Hi sir thanks for your answer, Do you know how I can correct these codes for SAS 9.1? because I have only SAS 9.1! thanks 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]

Mahmoud ★ Jordan, 2017-01-16 11:08 (2649 d 13:57 ago) @ Maryam Posting: # 16954 Views: 9,342	SAS Post reply
	Dear Dr Please let me know what is the design for your data 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! Since you repeatedly did not follow the Policy, this is the first warning. [Helmut]

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Paired vs. crossover

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Paired vs. crossover

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