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RegisterFDA: If RSABE not recommended in product-specific guidance [Power / Sample Size]
posted by Helmut 
– Vienna, Austria, 2017-05-23 15:15 (2523 d 13:34 ago) – Posting: # 17394
Views: 4,668
Salam Mahmoud,
Note that this guidance was recommended in August 2008 – way before the FDA considered reference scaling acceptable (Progesterone, April 2010).
Until the FDA updates the product-specific guidance, it is still worthwhile to give it a try. See the draft guidance “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA” lines 119–121 and footnote 10. For the FDA you have to submit the protocol for review anyway. See also Section VI.B. of “ANDA Submissions – Refuse-to-Receive Standards”.
❝ The problem here is that literature data archiving the PKs and output of previous BE studies on simvastatin show border ISV with CV around 30% (29% - 33%).
❝
❝ On the contrary, till the moment, the FDA guidance for BE study on Simvastatin doesn't involve reference scaling https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm089636.pdf
Note that this guidance was recommended in August 2008 – way before the FDA considered reference scaling acceptable (Progesterone, April 2010).
❝ Does the BE study of Simvastatin involve reference scaling due the border ISV of simvastatin derived from literature though the regulator doesn't imply that?
Until the FDA updates the product-specific guidance, it is still worthwhile to give it a try. See the draft guidance “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA” lines 119–121 and footnote 10. For the FDA you have to submit the protocol for review anyway. See also Section VI.B. of “ANDA Submissions – Refuse-to-Receive Standards”.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:
- Sample Size calculation and setting of BE limit base on Cmax or AUC mahmoud-teaima 2017-05-22 13:55 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- PK metric with largest variability – generally – drives the sample size Helmut 2017-05-22 15:16
- Regulatory guidance versus literature data mahmoud-teaima 2017-05-23 12:31
- FDA: If RSABE not recommended in product-specific guidanceHelmut 2017-05-23 13:15
- FDA: If RSABE not recommended in product-specific guidance mahmoud-teaima 2017-05-23 16:20
- FDA: If RSABE not recommended in product-specific guidanceHelmut 2017-05-23 13:15
- Regulatory guidance versus literature data mahmoud-teaima 2017-05-23 12:31
- PK metric with largest variability – generally – drives the sample size Helmut 2017-05-22 15:16
Ing. Helmut Schütz