Bioequivalence and Bioavailability Forum • EMA HVD/HVDPs

EMA HVD/HVDPs [Design Issues]

posted by Helmut – Vienna, Austria, 2015-08-16 15:27 (3472 d 04:22 ago) – Posting: # 15273
Views: 6,683

Dear all,

can somebody enlighten me? The EMA’s BE-GL states:

4.1.1 Study design / Alternative designs
[…] alternative well-established designs could be considered such as […] replicate designs e.g. for substances with highly variable pharmacokinetic characteristics (see section 4.1.10).
4.1.3 Subjects / Number of subjects
The number of subjects to be included in the study should be based on an appropriate sample size calculation.
4.1.10 Highly variable drugs or drug products
If an applicant suspects that a drug product can be considered as highly variable in its rate and/or extent of absorption, a replicate cross-over design study can be carried out.

What does that mean? If neither the CV of C_max or of AUC is expected to be >30% a replicate design cannot be carried out?

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Science Quotes

EMA HVD/HVDPsHelmut 2015-08-16 13:27 [Design Issues]
- EMA HVD/HVDPs ElMaestro 2015-08-16 19:00
  - An applicant suspects… Helmut 2015-08-16 23:02
    - Paranoia? d_labes 2015-08-17 09:31
      - Blindness! Helmut 2015-08-17 15:02