Bioequivalence and Bioavailability Forum • SABE is not ABEL

SABE is not ABEL [Software]

posted by Priyanka_kocheta – India, 2009-12-08 10:49 (6037 d 15:00 ago) – Posting: # 4442
Views: 10,236

Dear D labes

I use following Code for SABE and calculating the value of sigma2WR

%MACRO Analysis(Par,Code);

PROC MIXED Data=****;

CLASSES Sequence Subject Period Treat;

MODEL Ln&Par= Sequence Period Treat/ DDFM=SATTERTH;

RANDOM Treat/TYPE=FA0(2) SUB=Subject(sequence) g;

REPEATED/GRP=Treat SUB=Subject;

ESTIMATE 'T vs. R' Treat -1 1/CL ALPHA=0.05;

LSMEANS TReat/ pdiff;

ODS OUTPUT G=Gmatrix&Code;

ODS OUTPUT CovParms=COVEST&Code;

ODS OUTPUT LSMEANS=LSM&Code;

ODS OUTPUT ESTIMATES=EST&Code;

title5 "&Par Analysis";

Title6 'Lntransformed Data';

Run;



DATA LSM&Code; SET LSM&Code; _NAME_="Ln&Par"; ORD=&Code;

DATA EST&Code; SET EST&Code; _NAME_="Ln&Par"; ORD=&Code;

RUN;



proc sql;

create table &Par.11 as (select col1 as &Par.11 from gmatrix&Code where row=1);

run;

proc sql;

create table &Par.12 as (select col1 as &Par.12 from gmatrix&Code where row=2);

run;

proc sql;

create table &Par.22 as (select col2 as &Par.22 from gmatrix&Code where row=2);

run;

data BIO&Code;

MERGE &Par.11 &Par.12 &Par.22;

run;

PROC SQL;

create table &Par._est_Ref as (SELECT ESTIMATE as ref_L&Par FROM COVEST&Code WHERE group='Treat R');

RUN;



PROC SQL;

create table &Par._est_test as (SELECT ESTIMATE as test_L&Par FROM COVEST&Code WHERE GROUP='Treat T');

RUN;

data Combine&Code;

merge &Par._est_Ref &Par._est_test;

run;



data Switch&Code;

merge bio&Code combine&Code;



    data Switch&Code;

    set Switch&Code;

    switch_L&Par = (  &Par.11 + &Par.22 - (2* &Par.12));

    Intra_Var_REF_L&Par=ref_L&Par;



    Intra_CV_TEST_L&Par  = 100*sqrt(exp(test_L&Par)-1);

    Intra_CV_REF_L&Par  = 100*sqrt(exp(ref_L&Par)-1);



    Intra_CV_SWITCH_L&Par = 100*sqrt(exp(switch_L&Par)-1);

    Intra_CV_GLOBAL_L&Par = 100*sqrt((exp((test_L&Par + ref_L&Par)/2)+ switch_L&Par -1));



%mend Analysis;



*Actual analysis ;

%Analysis(Cmax,1);

%Analysis(AUCt,2);

%Analysis(AUCi,3);

data Global_Switch;

merge Switch1 Switch2 Switch3 ;

run;

proc print data=Global_Switch width=full double noobs;

title 'Project No: ;

title5 ' Intra Subject Variability' ;

var Intra_Var_REF_LCmax Intra_CV_TEST_LCMAX Intra_CV_REF_LCMAX Intra_CV_SWITCH_LCMAX Intra_CV_GLOBAL_LCMAX  ;

var Intra_Var_REF_LAUCt Intra_CV_TEST_LAUCT Intra_CV_REF_LAUCT Intra_CV_SWITCH_LAUCT Intra_CV_GLOBAL_LAUCT;

var Intra_Var_REF_LAUCi Intra_CV_TEST_LAUCI Intra_CV_REF_LAUCI Intra_CV_SWITCH_LAUCI Intra_CV_GLOBAL_LAUCI;

run;

DATA LSM;

title '  ';

SET LSM1 LSM2 LSM3;

GeoMean=exp(Estimate);

run;



DATA EST;

SET EST1 EST2 EST3;

TbyR=Exp(Estimate);

CI_Lower=Exp(Lower);

CI_Upper=Exp((Upper));

ttab=abs(tinv(0.95,df));

pw=(log(1.25)/StdErr-ttab);

Power= probt(pw,df);

run;





* Scaled BE Limit clacualtion;

data limit;

set Global_Switch(keep=Intra_Var_REF_LCmax Intra_Var_REF_LAUCt Intra_Var_REF_LAUCi);

run;

data limit_final;

set limit;

teta=0.796689;

Cmax_limit=exp(sqrt(teta*Intra_Var_REF_LCmax));

AUCt_limit= exp(sqrt(teta*Intra_Var_REF_LAUCt));

AUCi_limit=exp(sqrt(teta*Intra_Var_REF_LAUCi));

run;

data abc;

set limit_final (keep=Cmax_limit);

if (Cmax_limit ge 0) then BE_limit= Cmax_limit;

run;

data abc1;

set limit_final (keep= AUCt_limit);

if (AUCt_limit ge 0) then BE_limit= AUCt_limit;

run;

data abc2;

set limit_final (keep=AUCi_limit);

if (AUCi_limit ge 0) then BE_limit= AUCi_limit;

run;

data abc3;

set abc(keep=BE_limit) abc1(keep=BE_limit) abc2(keep=BE_limit);

run;



*Cheking the 1) Point Estimate 2) (Ut-Ur)2 <= teta*sigma2wr conditions;

data intra1;

merge est (keep=_name_ tbyr ci_lower ci_upper power) abc3;

if tbyr >=0.8 and tbyr <=1.25 then BE="YES";else BE='NO';

IF ci_UPPER<= be_LIMIT THEN BE='YES';else BE='NO';

IF TBYR < 0.8 and TBYR > 1.25 and CI_UPPER > BE_LIMIT THEN BE='NO';

RUN;

Now pl tell me where am wrong?

Regards,
PK

—
Regards,
PK

Complete thread:

Scaled Average Bioequivalence SAS Code Priyanka_kocheta 2009-12-03 12:12
- SABE SAS Code snippet d_labes 2009-12-03 13:42
  - Theta Helmut 2009-12-03 14:03
    - Adam Riese's t(h)eta d_labes 2009-12-03 15:14
      - Adam Riese's t(h)eta Helmut 2009-12-03 15:27
        
        T(h)eta d_labes 2009-12-03 15:52
        
        T(h)eta Helmut 2009-12-03 16:07
        
        Result Priyanka_kocheta 2009-12-08 07:29
        
        SABE is not ABEL d_labes 2009-12-08 09:19
        
        SABE is not ABELPriyanka_kocheta 2009-12-08 09:49
        
        The power to know is not knowledge d_labes 2009-12-08 12:10
- Scaled Average Bioequivalence SAS Code Elshafeey 2011-11-02 21:46