Bioequivalence and Bioavailability Forum • Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design

Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design [RSABE / ABEL]

posted by Sereng – USA, 2022-01-28 22:40 (810 d 20:47 ago) – Posting: # 22759
Views: 1,626

❝ Can you post a link to the guidance?

Hi Helmut, many thanks for your response. Below are the PSG links, one PSG asks you to refer to the second, although the first one may have the information (Sorry, I don't know how to attach the document here). I look forward to your guidance. Regards

https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levothyroxine_Sodium%20capsules_NDA%20021924_RC%20Oct%202018.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/psg/Warfarin_Sodium_tab_09218_RC12-12.pdf

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! [Helmut]

Complete thread:

Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Sereng 2022-01-28 19:37 [RSABE / ABEL]
- Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation Design Helmut 2022-01-28 21:06
  - Sample Size Efficiency of 4-Period, 2-Seq, 2-Formulation DesignSereng 2022-01-28 21:40
    - NTIDs Helmut 2022-01-29 12:19