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pash413 ★ India, 2013-10-21 11:04 (4625 d 13:19 ago) Posting: # 11714 Views: 6,941 |
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Hello Can any one suggest the sample size requirement for food effect study. Study is to be submitted for USFDA (NDA 505b2). Edit: Category changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2013-10-21 15:50 (4625 d 08:32 ago) @ pash413 Posting: # 11718 Views: 5,679 |
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Hi Pash, all studies in an NDA are exploratory by nature. Only in bioequivalence (ANDAs or SUPAC) you need a justified size size, since these studies are confirmatory. For the FDA the minimum sample size is twelve eligible subjects – but might be larger depending on the variability. Since this is an NDA, I guess you already have performed other BA studies. This should give you a rough idea about the sample size. — 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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jag009 ★★★ NJ, 2013-10-21 17:44 (4625 d 06:38 ago) (edited on 2013-10-22 17:52) @ Helmut Posting: # 11720 Views: 5,657 |
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Hi Helmut, Something from my previous experience... Be careful though as it depends on whether one wants to have a food effect or not. In my previous company we strided for no food effect in our NDA 505(b)2 controlled release formulation and we played safe in showing that the fed vs fasted study passed BE by ensuring that the power was sufficient (as in passing the 80-125%). Of course if there was a food effect then though luck but it would be advantageous to have a no food effect product (Unless product needs to be given with food to enhance BA or reduce AEs). Thanks John 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! [Dr_Dan] |
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Helmut ★★★ Vienna, Austria, 2013-10-22 21:55 (4624 d 02:27 ago) @ jag009 Posting: # 11727 Views: 5,732 |
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Hi John, true! I think that FDA is (or was?) somewhat flexible when it comes to NDAs. If I recall it right, there was a group (task force? ad hoc working party?) led by Larry Lesko with the main purpose to assess “failed” studies of innovators. If a study failed at the lower CL they looked at the phase III efficacy data of a lower dose and if it failed at the upper CL they looked at the safety data of a higher dose.  Of course it is nice to show no food effect because otherwise it may go straight into the label. On the other hand are innovators really unhappy about a food effect? Generic companies would have to run both fasting and fed studies later on…— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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jag009 ★★★ NJ, 2013-10-22 22:44 (4624 d 01:38 ago) @ Helmut Posting: # 11728 Views: 5,754 |
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Hi Helmut! ❝ true! I think that FDA is (or was?) somewhat flexible when it comes to NDAs. If I recall it right, there was a group (task force? ad hoc working party?) led by Larry Lesko with the main purpose to assess “failed” studies of innovators. If a study failed at the lower CL they looked at the phase III efficacy data of a lower dose and if it failed at the upper CL they looked at the safety data of a higher dose. True. One of my old products had a borderline food effect (failed 90% CI by ~1%) and FDA gave us the no food effect label. But if you are off by a lot (a few percent?) then they probably would not give you the no food label unless you have clinical data. Correct me if I am wrong but most modified release (b)2 submissions claim therapeutic equivalence so to avoid clinical studies, in such case then they are stuck with proving no food effect via BE... ❝ On the other hand are innovators really unhappy about a food effect? Generic companies would have to run both fasting and fed studies later on… I meant for ER products that generics will have to run fast and fed. An ER fed only product is more or less a turd unless it is due to safety (If it's formulation driven). John |
Ing. Helmut Schütz