Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-10-17 05:57 CEST (UTC+2h)
 
Maryam
Junior

Iran,
2017-01-13 16:28

Posting: # 16946
Views: 3,217
 

 SAS [Software]

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::no:

How should I solve this problem?:clap:

thanks:ok:
Mahmoud
Junior

Jordan,
2017-01-15 08:56

@ Maryam
Posting: # 16947
Views: 2,851
 

 SAS

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

mahmohsen111[image]yahoo.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
Hero
Homepage
Vienna, Austria,
2017-01-15 12:16

@ Mahmoud
Posting: # 16948
Views: 2,858
 

 Paired vs. crossover

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 AUC0–τ vs. AUC0–∞.
  • 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?

[image]All the best,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
Maryam
Junior

Iran,
2017-01-15 16:44

@ Helmut
Posting: # 16951
Views: 2,815
 

 Paired vs. crossover

» 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
Regular

Portugal,
2017-01-17 15:35

@ Maryam
Posting: # 16967
Views: 2,661
 

 Paired vs. crossover

@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
Hero
Homepage
Vienna, Austria,
2017-01-18 12:57

@ DavidManteigas
Posting: # 16972
Views: 2,492
 

 Picky

Hi David,

» proc glm data=replicate;

<nitpicking>

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.

[image]All the best,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
DavidManteigas
Regular

Portugal,
2017-01-27 15:03

@ Helmut
Posting: # 16996
Views: 1,857
 

 Picky

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 :-D

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
Junior

Iran,
2017-01-15 16:31

@ Mahmoud
Posting: # 16950
Views: 2,826
 

 SAS

» 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
Junior

Jordan,
2017-01-15 14:36

@ Maryam
Posting: # 16949
Views: 2,834
 

 SAS

» 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
Junior

Iran,
2017-01-15 16:50

@ Mahmoud
Posting: # 16952
Views: 2,813
 

 SAS

» 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
Junior

Jordan,
2017-01-16 10:08

@ Maryam
Posting: # 16954
Views: 2,782
 

 SAS

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]
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,394 Posts in 3,725 Threads, 1,071 registered users;
27 users online (0 registered, 27 guests).

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed