Deconvolution sample size and design issues [Power / Sample Size]

posted by mittyri – Russia, 2023-02-09 15:40 (520 d 00:43 ago) – Posting: # 23450
Views: 2,366

Dear all!

I am puzzled with EMA MR Guide:

5.1.1. It should be demonstrated that the modified release formulation has the claimed release characteristics. It is encouraged to employ deconvolution of the concentration-time data for the modified release formulation against an appropriate immediate release formulation (see Appen­dix II for more detail) in order to obtain the cumulative absorption (or in vivo release) versus time profile for the modified release formulation.

I looked into Appendix II, it is named as "in vivo skin adhesion", nothing more. Is there another Appendix I missed?

1. Is it possible to evaluate the number of subjects used for the following cumulative absorption estimate?
2. Is it possible to get exp1/A1/exp2/A2 terms from non-IV data (say IR)?
3. Are there any examples of designs to be used for Deconvolution? As far as I can see, 3 periods are necessary, IV, IR, MR
4. I see many papers explaining deconvolution in range of IVIVC, are there any examples of EPARs you know where deconvolution is used clearly 'to obtain the cumulative absorption (or in vivo release) versus time profile for the modified release formulation'

Kind regards,
Mittyri

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