regarding elevation of lab parameters [GxP / QC / QA]

posted by Varsha – 2014-09-02 08:47 (4303 d 01:20 ago) – Posting: # 13450
Views: 5,825

❝ Hello ELMaestro,


Thanks for your response. Few clarification which you require:

❝ Let's hear what drug this is. Makes it easier to guesswork a little.


The drug is tolterodine Tartrate,

❝ Was ESR measured in-house or out?


ESR measured from an outsourced diagonistic lab.

❝ Did you review the ESR measurements where it took place?


till now we didin'e talk with the lab.

❝ Anything else out of the ordinary in the trial?


rest is satisfactory in the trial.

❝ Did you see it in true quanta in both T and R?


the events occured in both test and reference.

Kind regards
Varsha

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