Bioequivalence and Bioavailability Forum

❝ Is there any acceptance criteria for the interference of drug and IS in

❝ predose study sample?

❝ What is the exact acceptance criteria to accept a predose sample (without

❝ drug and IS) [...]

Generally in the predose study sample the interference at the RT of drug and IS should be in lieu with the selectivity criteria of the method validation SOP. So for analyte it would be 20% of the area of LLOQ and for IS it would be 5% (or as stated in your SOP) of the mean IS area of passing CC and QC of that particular batch.

Though I dont know any reference guideline for your query, however the selectivity acceptance criteria is according to FDA guideline.

❝ [...] and a predose sample (with IS)?

For a pre dose sample with IS the acceptance criteria is the concn. of predose sample (with IS) should be less than 5% of the Cmax of the particular period.

Reference is from FDA: http://www.fda.gov/cder/guidance/5356fnl.pdf http://web.archive.org/web/20150226060249/http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf

I hope this will help

Thanks

Bani

---

Edit: Link corrected to latest archived copy. [Helmut]

Hai reddy,

There is no acceptance criteria for predose samples.
But predose sample also considered as blank matrix. So we have criteria for interference in blank matrix (selectivity) mentioned in FDA guidelines. So same will be applicable for predose sample also. However you should follow as per your predefined inhouse SOPs.

with regards,
Rambabu.S

---

Edit: Full quote removed. Please see this post! [Helmut]

Dear All,

Thanks for your information.

Regards,
Reddy

---

Edit: Full quote removed. Please see this post! [Helmut]