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Pharma_88 ☆ India, 2024-05-15 07:37 (244 d 21:42 ago) Posting: # 23996 Views: 3,299 |
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Dear All, Greetings!! 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. Regards, Pharma_88 — Regards, Pharma_88 |
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Ohlbe ★★★ France, 2024-05-15 11:39 (244 d 17:39 ago) @ Pharma_88 Posting: # 23997 Views: 2,867 |
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Dear Pharma_88, You are referring to a general FDA guidance, which gives general recommendations. Did they publish a product-specific guidance for your product ? It would overrule the general guidance. The type of study to be performed depends on how the drug is normally used according to its labelling. For instance:
— Regards Ohlbe |
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Pharma_88 ☆ India, 2024-05-17 12:06 (242 d 17:12 ago) @ Ohlbe Posting: # 23998 Views: 2,740 |
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Dear Ohlbe, Thank you for responding. Drug is Olaparib and OGD recommends Two-way crossover Steady State PK study. One of our client wish to conduct single dose BE study as a conventional design without interrupting ongoing treatment of patient. Now whether its a feasible by taking appropriate measures of clinical safety? Regards, Pharma_88 Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe] — Regards, Pharma_88 |
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Ohlbe ★★★ France, 2024-05-17 15:45 (242 d 13:34 ago) @ Pharma_88 Posting: # 23999 Views: 2,728 |
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Dear Pharma_88, Well, olaparib is to be taken every day, twice a day, and has a terminal half-life of 15 hours. How could you possibly do a single-dose BE in patients, without treatment interruption ? Even if you were to enrol patients requiring treatment and who have not started it yet, and do a 72-hour PK after their first dose: that would mean delaying the next doses, which would trigger some ethical concerns, and you would need to go for parallel design. — Regards Ohlbe |
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Pharma_88 ☆ India, 2024-05-20 08:50 (239 d 20:28 ago) @ Ohlbe Posting: # 24002 Views: 2,690 |
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Dear Ohlbe, Thank you for response. Could you please let me know how the parallel design will be planned? As per my understanding... Screening >> Stabilization Period (with the approved product) >> Randomization (T/R) >> EOS Regards, Pharma_88 — Regards, Pharma_88 |
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Helmut ★★★   Vienna, Austria, 2024-05-20 09:57 (239 d 19:21 ago) @ Pharma_88 Posting: # 24004 Views: 2,692 |
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Hi Pharma_88, if you want to deviate from a guidance, you have to initiate a Controlled Correspondence with the FDA’s OGD giving a justification. ‘Because my client wants it’ will not suffice. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Pharma_88 ☆ India, 2024-05-21 10:32 (238 d 18:47 ago) @ Helmut Posting: # 24005 Views: 2,608 |
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Dear Helmut, Thank you. Yes for For submission study, will definitely initiate CC with FDA. Since this is a pilot study where main objective is to assess the possibility of the single dose administration effect on pharmacokinetic as well as safety. So any possibility to conduct parallel design study? if yes, how it will be designed? — Regards, Pharma_88 |
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Ohlbe ★★★ France, 2024-05-21 14:41 (238 d 14:37 ago) @ Pharma_88 Posting: # 24006 Views: 2,596 |
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Dear Pharma_88, ❝ Thank you for response. Could you please let me know how the parallel design will be planned? No. I did mention parallel design, as this was the only option I could see with a single-dose administration rather than a steady-state study, but I would certainly not advise to do it. The FDA "recommends" a crossover steady-state study for good reasons. — Regards Ohlbe |
Ing. Helmut Schütz