README File For FDA SAS Drug Formulation Stability Program

             Prepared by Moh-Jee Ng, Division of Biometrics
                Center for Drug Evaluatuion and Research
                      Food and Drug Administration
                           Date March 23, 1992


The SAS/PC program system STAB is written to perform the
expiration dateing period estimation based on linear regression
analysis.  The statistical foundation of the program was
documented in 1987 "GUIDELINE FOR SUBMITTING DOCUMENTATION FOR
THE STABILITY OF HUMAN DRUGS AND BIOLOGICS."

SAS/PC version 6.03 is required to run the program.   DOS version
3 or later version is assumed in these instructions, but not
required.

To install

    Make sure that your config.sys file contains the lines

    device=c:\dos\ansi.sys
    files=50

    Reboot the system if changes are made in your config.sys
file.  If you do not keep the DOS operating system in directory
c:\dos, give the appropriate directory.  Without ansi.sys, you
cannot leave the SAS display manager by the "x" command.  Without
sufficient file handles, the stability program will not run.

To load the software

    Load the software (presumably from floppy drive A, to the
current default drive and SAS directory) with the commands

    mkdir \sas\stab
    xcopy a:*.* \sas\stab

    or equivalent procedure for loading.

    As a precaution against accidental modification of the source
files, you might want to enter

    attrib +r \sas\stab\*.*

The STAB system contains a data file, six SAS macro files and an
optional SAS/Graph file.

    STAB.DAT is a SAS control file, to which the user adds
current variable values, titles, and the DATA.  STABNC.DAT is an
alternate SAS control file with a few comments.

    ANALYS1.SAS to ANALYS6.SAS are the SAS macro programs

    STABGRAF.SAS is an optional program for SAS/GRAPH

    README.BAT and HELPSTAB.BAT are optional files to display
this document.


To use the STAB system:

1.  Make a duplicate of the stab.dat file, to avoid changing the
    original, by the following or equivalent:

    copy \sas\stab\stab.dat \sas\stab\stab1.dat

2.  Start SAS (presumably using the Display Manager, with \SAS as
    the default directory.)


3.  Load STAB1.DAT by entering the following on the command line

    INCLUDE 'STAB\STAB1.DAT'


4.  When STAB1.DAT is loaded, enter the data and other
    modifications, as per the instructions given in comments in

    STAB1.DAT


5.  After completing data and information entry, enter

    SUBMIT

    on the command line to run the STAB system.


6.  Check the LOG listing for errors, and if none, save the
    output listing (LST) as detailed in the comments given in
    STAB.DAT.




7.  If you want high resolution SAS graphs, enter

    CLEAR

    on the command line of the program window if a program is
    visible.

8.  The STABGRAF.SAS file uses a permanent dataset created by
    STAB.DAT, so STAB.DAT need to be run before STABGRAF.SAS. 
    Load STABGRAF.SAS by entering on the command line

    INCLUDE 'STAB\STABGRAF.SAS'

9.  Make any modifications needed (check graphics device type and
    the axis scales) and run by entering
    SUBMIT
    on the command line.

    The program may run through a series of graphs.  After
    viewing the current graph, press the space bar once.