Single dose PK study on Patients [Design Issues]

posted by Pharma_88 – India, 2024-05-15 07:37 (35 d 05:23 ago) – Posting: # 23996
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Dear All,


Would like to your feedback/opinion on conduction of Bioequivalence study (PK end point study) as a single dose administration for a product intended to use for ovarian cancer patients? as per USFDA guideline, its mentioned that steady state study is required. Clause from guideline is captured below.

When safety considerations suggest using patients who are already receiving a medication, often the only approach to establish BE without disrupting a patient’s ongoing treatment is in a steady state study. If a steady-state study is used, we recommend that applicants carry out appropriate dosage administration and sampling to demonstrate the attainment of steady state.



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