suchit_bhavsar
★    

India,
2014-06-26 15:45
(4382 d 13:24 ago)

Posting: # 13150
Views: 8,211
 

 Steady State SAS Code [General Sta­tis­tics]

Post reply
Hello to All,

I need to validate SAS code of steady state study for that I have taken data from Canada guideline part B (1996) from table 12G and 12H. Below table represents the outcome of mine SAS code.
Which is not matching with Canadian guideline result :confused:.

Source                  DF      Type I SS       Mean Square     F Value Pr > F
Sequence                1       0.01325957      0.01325957      0.38    0.5414
Subject(Sequence)       10      1.22058634      0.12205863      3.53    0.0055
Period                  1       0.01824931      0.01824931      0.53    0.4744
Form                    1       0.2206856       0.2206856       6.39    0.0185
Subjec*Form(Sequenc)    10      0.56173147      0.05617315      1.63    0.1589
Time                    1       0.03394077      0.03394077      0.98    0.3315
Time*Sequence           1       0.11775951      0.11775951      3.41    0.0772
Time*Subjec(Sequenc)    10      0.33034103      0.0330341       0.96    0.5037
Time*Period             1       0.06284471      0.06284471      1.82    0.19
Time*Form               1       0.02738506      0.02738506      0.79    0.3822
Time*Subj*Form(Sequ)    10      0.29432572      0.02943257      0.85    0.5869


Source          DF      Sum of Squares  Mean Square     F Value Pr > F
Model           47      2.90110908      0.06172573      1.79    0.0634
Error           24      0.82927742      0.03455323
Corrected Total 71      3.7303865

The SAS code is as follows:

Proc glm data= lnconc;
Class Subject seq trtmnt period;
Model pkvalue = Seq subject(seq) period trtmnt subject*trtmnt(seq) time time*seq time*subject(seq) time*period time*trtmnt time*trtmnt*subject(seq)/ss1;
test h= time e= time*subject(seq)/ htype=1 etype=1;;
test h= time*trtmnt e= time*trtmnt*subject(seq)/ htype=1 etype=1;
Run;
quit;

Kindly suggest me where I’m doing a mistake. :confused::confused:

Pls suggest how to upload excel file.

Thanks and Regards,

Suchit

Edit: Uploading Excel-files is not (and will never be) possible. Please see the Forum’s FAQ #11. [Helmut]
 
jag009
★★★

NJ,
2014-06-27 00:42
(4382 d 04:26 ago)

@ suchit_bhavsar
Posting: # 13151
Views: 6,847
 

 Steady State SAS Code

Post reply
Hi,

Are you sure that there are so many factors in the model?

To post data, just copy and paste the data into your message and separate the values by a delimiter "," or " ".

John
 
suchit_bhavsar
★    

India,
2014-06-27 09:18
(4381 d 19:51 ago)

(edited on 2014-06-27 09:44)
@ jag009
Posting: # 13152
Views: 6,645
 

 Steady State SAS Code

Post reply
Thanks John,

As per Canadian guideline I have taken all these terms in model, but I’m not sure whether I’m doing right or wrong. Pls find the data which is taken from the Canadian guideline and kindly provide your suggestion.

Can we take time in class variable?

Subject Sequence Period trtmnt Time Cpd
1          RT       2     T     6    41
1          RT       2     T     7    46
1          RT       2     T     8    50
2          TR       1     T     6    44
2          TR       1     T     7    31
2          TR       1     T     8    18
3          TR       1     T     6    45
3          TR       1     T     7    51
3          TR       1     T     8    53
4          RT       2     T     6    48
4          RT       2     T     7    31
4          RT       2     T     8    45
6          TR       1     T     6    41
6          TR       1     T     7    43
6          TR       1     T     8    48
7          RT       2     T     6    36
7          RT       2     T     7    49
7          RT       2     T     8    60
8          RT       2     T     6    34
8          RT       2     T     7    36
8          RT       2     T     8    38
9          RT       2     T     6    24
9          RT       2     T     7    47
9          RT       2     T     8    32
10         TR       1     T     6    37
10         TR       1     T     7    47
10         TR       1     T     8    31
12         RT       2     T     6    35
12         RT       2     T     7    61
12         RT       2     T     8    28
13         TR       1     T     6    31
13         TR       1     T     7    38
13         TR       1     T     8    25
14         RT       2     T     6    39
14         RT       2     T     7    39
14         RT       2     T     8    56
1          RT       1     R     6    47
1          RT       1     R     7    43
1          RT       1     R     8    42
2          TR       2     R     6    38
2          TR       2     R     7    46
2          TR       2     R     8    40
3          TR       2     R     6    63
3          TR       2     R     7    56
3          TR       2     R     8    61
4          RT       1     R     6    32
4          RT       1     R     7    36
4          RT       1     R     8    38
6          TR       2     R     6    35
6          TR       2     R     7    37
6          TR       2     R     8    40
7          RT       1     R     6    47
7          RT       1     R     7    52
7          RT       1     R     8    49
8          RT       1     R     6    31
8          RT       1     R     7    34
8          RT       1     R     8    35
9          RT       1     R     6    46
9          RT       1     R     7    47
9          RT       1     R     8    55
10         TR       2     R     6    39
10         TR       2     R     7    44
10         TR       2     R     8    43
12         RT       1     R     6    46
12         RT       1     R     7    49
12         RT       1     R     8    47
13         TR       2     R     6    39
13         TR       2     R     7    49
13         TR       2     R     8    42
14         RT       1     R     6    41
14         RT       1     R     7    44
14         RT       1     R     8    56

Thanks and Regards,

Suchit

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! [Ohlbe]
Edit: Data BBCoded (as John suggested). Please do not post tabulators; see also here. [Helmut]
 
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2014-06-27 15:56
(4381 d 13:13 ago)

@ suchit_bhavsar
Posting: # 13156
Views: 6,716
 

 Obsolete since July 2012!

Post reply
Hi Suchit,

why do you bother setting up a statistical analysis according to an (18 years old) obsolete guid­ance – which has been removed from Health Canada’s website in 2012 – and is only available in the [image] Internet Archive any more? See the guidance published on May 22, 2012.

The documents which will be superseded by these guidances when they come into effect, are as follows:

  1. Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies – Part A: Oral Dosage Formulations Used for Systemic Effects (1992).
  2. Report C (of the Expert Advisory Committee on Bioavailability and Bioequivalence): Report on Bioavailability of Oral Dosage Formulations, Not in Modified Release Form, of Drugs Used for Systemic Effects, Having Complicated or Variable Pharmacokinetics (1992).
  3. Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies – Part B: Oral Modified Release Formulations (1996).
  4. Draft Policy: Bioequivalence Requirements: Drugs Exhibiting Non-Linear Pharma­co­ki­ne­tics (2003).
  5. Notice to industry: Removal of Requirement for 15% Random Replicate Samples (2003).
  6. Draft Guidance for Industry: Use of Metabolite Data in Comparative Bioavailability Studies (2004).
  7. Notice to industry: Bioequivalence requirements for combination drug products (2004).
  8. Guidance for Industry: Bioequivalence Requirements: Comparative Bioavailability Studies Conducted in the Fed State (2005).
  9. Notice to Industry: Bioequivalence Requirements for Drugs for Which an Early Time of Onset or Rapid Rate of Absorption Is Important (rapid onset drugs) (2005).
  10. Notice to Industry: Bioequivalence Requirements for Long Half-life Drugs (2005).
  11. Guidance for Industry: Bioequivalence Requirements: Critical Dose Drugs (2006).

These guidance documents will come into effect for submissions filed on or after July 1, 2012, with the following exceptions. Where the requirements in these guidance docu­ments are reduced relative to existing guidance, the reduced requirements will be effective imme­di­ate­ly. Where the requirements in these guidance documents are increased relative to exist­ing guidance, the increased requirements will only be applied to studies initiated on or after July 1, 2012.


BTW, any multivariate method assessing whether steady state was achieved is not desirable, IMHO. If either time or time × formulation is significant, you would have to throw away the entire study. That’s stupid, but HC improved and harmonized with the FDA and EMA:
According to the current guidance, Section 2.7.2 j) …

Pre-dose concentrations determined immediately before a dose at steady state (Cpd).

… have to be reported only.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
 
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
118 visitors (0 registered, 118 guests [including 12 identified bots]).
Forum time: 05:09 CEST (Europe/Vienna)

Ignorance more frequently begets confidence
than does knowledge.    Charles Darwin

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5