Regulatory guidance versus literature data [Power / Sample Size]

posted by mahmoud-teaima  – 2017-05-23 14:31 (2825 d 19:53 ago) – Posting: # 17392
Views: 5,124

Salam Helmut,
Thank you for the detailed, evidence-proofed explanation.

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/.../Guidances/ucm086171.pdf
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm089636.pdf

So, the straightforward question is:
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?

Greetings.

Mahmoud Teaima, PhD.

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