Isotretinoin Capsules 40 mg fed studies [Study As­sess­ment]

posted by Venkata Chaitanya Reddi – India, 2023-06-14 12:19 (173 d 22:42 ago) – Posting: # 23590
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Hi All,

Greeting for the Day!!!

Regarding Isotretinoin Capsules 40 mg fed studies,
for the test product, the reported arithmetic mean Cmax of baseline-corrected isotretinoin is 2326.2448 ng/mL for fed BE study which is failed and 912.1610 ng/mL is reported for repeat fed BE study with same test product, while the bioanalytical method and bioanalytical site for the two BE studies are same.

Specifically, the Cmax and AUCs in the failed fed BE study are more than two-fold higher than those reported for the repeat fed BE study.

What could be the reason(s) for the observed significant difference in Cmax.

Please provide the available literature to support the observed difference on the bioequivalence evaluation.

Appreciate your help in advance.

Thank you,
Venkata Chaitanya Reddi.

Edit: Category changed; see also this post #1[Helmut]

Venkata Chaitanya Reddi

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