Dear All,
Plz find the BLQ step and let know whether it is correct or not.
Expalin me how to do performance qualification for winonlin. If any literature available plese give reference. i tried in canada part II guidelines but im not getting it. Please do the needful.
Regards
Raja [file name=BLQ_Step.doc size=654336]http://www.pharsight.com/extranet/media/kunena/attachments/legacy/files/BLQ_Step.doc[/file]
Moderator note: please also read the section on "Status code transformations" in Chapter 3 - Workbooks of the User guide.
BLQ Step and PQ for winnonlin
Started by
Ramesh
, Jun 23 2010 09:10 AM
2 replies to this topic
#2
Simon Davis
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Posted 23 June 2010 - 09:53 AM
To your overall question on PQ Validation there are various ways to approach this; try reviewing one of our recorded webinars; e.g. http://pharsight.com....php#replay_008, it's not an M & S question.
Similarly guideline discussion would be better placed in "General WinNonlin Classic Discussion Forum"; I don't understand your question;
If any literature available plese give reference. i tried in canada part II guidelines but im not getting it.
I know you are aware of the various guidelines that have been kindly collated here;
http://bebac.at/Guidelines.htm
If you have some specific question please re-formulate it and post to the appropriate forum (I will check you access level and resolve it for tomorrow morning).
Regarding your questions on the BLQ wizard of WNL Classic;
Step I:
Status CodeValues Variable - Should I keep blank?
this need only be completed if you have a column containing this data e.g. "result comments" or "flag", from your screen shot it appears not so leave blank.
LLOQ Variable - Should I keep blank?
this need only be completed if you have a column containing this data e.g. "LLOQ" that would be populated with a value that might change for sample to sample i.e. different analytes in one column, from your screen shot it appears not so leave blank.
Static Value - Should I check the column or not?
this should be checked if you have a single value of LLOQ for all samples, from your question below I would suggest YES check the box
LLOQ - Should I enter LLOQ value (e.g. 0.500 ng/mL or should I keep blank)
YES if it does not change enter 0.500 here, units will be assumed to be the same as those of your concentration column
STEP - III Explain about how to use these columns
Depends what your SOP/data guidelines require - it is a toolkit to give you a degree of flexibility in changing your data in a refreshable and trackable manner
Non-numeric:
No peak
M
BLQ
NR
First I am using No Peak, Suppose if I use second M what shou8ld I use for remaining column
I don't know what you mean by "second M", if you have more than one non-numeric code there should be a line for each one
Unconditional substitution: - all values replaced regardless of position in the profile
Before Tmax - 0 (Is it correct) if that is what your SOP says, seems reasonable for Extravascular dosing to me
After Tmax - BLQ (Is it correct) the kit is expecting you to substitute a NUMBER or MISSING in this toolkit since a non-numeric value would be ignored for calculations and plots anyway
First of consecutive after Tmax- BLQ (Is it correct)
After First of consecutive after Tmax- BLQ (Is it correct)
Use When < LLOQ:
When should I give Yes and no If set to YES this option will make the requested changes when a numeric values is less than your LLOQ as well as when it finds the specified non-numeric values i.e. 0.499 would also be processed by this rule set.
Finally I really would suggest that if you are looking to validate the software you plan to do that with the current release Phoenix WinNonlin 6.1
Similarly guideline discussion would be better placed in "General WinNonlin Classic Discussion Forum"; I don't understand your question;
If any literature available plese give reference. i tried in canada part II guidelines but im not getting it.
I know you are aware of the various guidelines that have been kindly collated here;
http://bebac.at/Guidelines.htm
If you have some specific question please re-formulate it and post to the appropriate forum (I will check you access level and resolve it for tomorrow morning).
Regarding your questions on the BLQ wizard of WNL Classic;
Step I:
Status Code
this need only be completed if you have a column containing this data e.g. "result comments" or "flag", from your screen shot it appears not so leave blank.
LLOQ Variable - Should I keep blank?
this need only be completed if you have a column containing this data e.g. "LLOQ" that would be populated with a value that might change for sample to sample i.e. different analytes in one column, from your screen shot it appears not so leave blank.
Static Value - Should I check the column or not?
this should be checked if you have a single value of LLOQ for all samples, from your question below I would suggest YES check the box
LLOQ - Should I enter LLOQ value (e.g. 0.500 ng/mL or should I keep blank)
YES if it does not change enter 0.500 here, units will be assumed to be the same as those of your concentration column
STEP - III Explain about how to use these columns
Depends what your SOP/data guidelines require - it is a toolkit to give you a degree of flexibility in changing your data in a refreshable and trackable manner
Non-numeric:
No peak
M
BLQ
NR
First I am using No Peak, Suppose if I use second M what shou8ld I use for remaining column
I don't know what you mean by "second M", if you have more than one non-numeric code there should be a line for each one
Unconditional substitution: - all values replaced regardless of position in the profile
Before Tmax - 0 (Is it correct) if that is what your SOP says, seems reasonable for Extravascular dosing to me
After Tmax - BLQ (Is it correct) the kit is expecting you to substitute a NUMBER or MISSING in this toolkit since a non-numeric value would be ignored for calculations and plots anyway
First of consecutive after Tmax- BLQ (Is it correct)
After First of consecutive after Tmax- BLQ (Is it correct)
Use When < LLOQ:
When should I give Yes and no If set to YES this option will make the requested changes when a numeric values is less than your LLOQ as well as when it finds the specified non-numeric values i.e. 0.499 would also be processed by this rule set.
Finally I really would suggest that if you are looking to validate the software you plan to do that with the current release Phoenix WinNonlin 6.1
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