Bioequivalence and Bioavailability Forum

Dear All,

I would request you if you can help me in this regard:

Non-clinical SEGMENT-2 TOX STUDIES aligning to GLP are carried out in lab 'A' which is a GLP certified Lab in India following OECD principles and the toxicokinetic and formulation samples have been sent to Lab 'B' which is accreditated by NABL aligning to ISO/IEC 17025:2005 standard, and after the study the Lab 'A' will compile the data received from Lab 'B' as per GLP and submit to USFDA GLP. My query is - the bioanalytical data generated from Lab 'B' (which has NABL accreditation and Quality and Technical system aligning to ISO/IEC 17025:2005) is acceptable by USFDA GLP or not? The live phase and pharmacokinetic analysis will be done in GLP certified Lab 'A' and final report is also be generated by Lab 'A'only.

Please guide me in this matter, I had looked into OECD guidelines also but I could find the relevant answer for my query.