ICH M13A: Changes to Step 2 [BE/BA News]
Dear all,
a tricky part.
a tricky part.
- Draft (4. DOCUMENTATION, page 27)
Module 2.7.1 of the CTD should list all relevant BE studies conducted regardless of the study outcome. Full study reports should be provided for the BE study(ies) upon which the applicant relies for approval. For all other studies, synopses of the study reports (in accordance with ICH E3) are sufficient. However, complete study reports for these studies should be available upon request.
- Final (page 22)
Unchanged.
- Question
If the relevant BE studies conducted with the same formulation under the same study conditions result in different BE outcomes, what action should be taken?
- Answer
M13A recommends that all relevant BE studies conducted, regardless of the study outcome, should be provided. If, for a particular formulation at a particular strength, multiple pivotal studies result in inconsistent BE conclusions, the totality of the evidence should be considered. The applicant should discuss the results and justify the BE claim. When relevant, a combined analysis of all studies may be considered as a sensitivity analysis in addition to the individual study analyses. It is not acceptable, however, to pool studies which fail to demonstrate BE without a study that passes.
If there are differences in the study conditions, e.g., sampling times, fasting or fed conditions, or method of administration, pooling is not justifiable. A different number of subjects is not considered a difference in study conditions.
- If for a particular formulation at a particular strength multiple studies have been performed some of which demonstrate bioequivalence and some of which do not, the body of evidence must be considered as a whole. Only relevant studies […] need be considered. The existence of a study which demonstrates bioequivalence does not mean that those which do not can be ignored. The applicant should thoroughly discuss the results and justify the claim that bioequivalence has been demonstrated. Alternatively, when relevant, a combined analysis of all studies can be provided in addition to the individual study analyses. It is not acceptable to pool together studies which fail to demonstrate bioequivalence in the absence of a study that does.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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