Bioequivalence and Bioavailability Forum

Dear IK!

❝ During subject sample analysis, in a batch individual repeats (dilution

❝ integrity samples) were also analysed along with DI QCs (dilution

❝ integrity quality control samples). In that batch DI QCs failed to meet

❝ specifications.

❝

❝ Now, should I reject the batch? (or) Should I code only the DI samples and

❝ repeat again?

Interesting approach. IMHO once you have validated the method for dilution integrity, there is no need to run 'DI QCs' (to be honest, never heard this term before). Don't you have an SOP for such a situation? I would say:

• No need to repeat the batch of subject samples, since QCs passed.
  
• Repeat diluted samples, since DI QCs failed.

Opinions of other members about the need of DI QCs highly appreciated.

P.S.: Consider signing you posts with something more close to a name than only initials.