Regarding Protocol Deviation [GxP / QC / QA]

posted by Dr.Pravin – Ahmedabad, 2009-02-12 13:54 (5932 d 21:17 ago) – Posting: # 3230
Views: 5,600

Dear Prashant,

thanks for reply,

the case is for the prior to dosing of P1,

if protocol specify that No water except the 240 ± 02 mL given with drug administration will be allowed from 01 hour before to 01 hour after dose administration.

so what to do in such case, consider as protocol deviation or protocol non complience.
—
Dr.Pravin Ahir
Co-Investigator,
Accutest Research Pvt.Lab.(I), Ltd.
Ahmedabad

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