Isotretinoin Capsules 40 mg fed studies [Study As­sess­ment]

posted by dshah  – India/United Kingdom, 2023-06-16 10:27 (371 d 16:34 ago) – Posting: # 23601
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Dear Venkata!

❝ We believe that these are the potential causes.


❝ but, we are using same test product batch no. and reference product batch no was different.


I think you are getting it wrong. The reference standard means the API used in CC and QC preparation. The change in reference standard, your reference lot, Instrument change can directly have impact on your S/N ratio and can give you different level. Can you confirm that the S/N and then the area of standards and CC remains similar between the study? This can give you a good idea that there is some change.
Further your CC range remains same indicating that the levels were anticipated.
As the study sample analysis is performed using same instrument, reference standard (for same study)- it would have minimal impact on outcome i.e. ratio and 90% CI.
If you are trying to corelated the failed study and change in concentration level- it may not be fruitful.

Regards,
Divyen

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