Product-specific advice (Benserazide+levo­dopa) [Design Issues]

posted by Mikalai  – Belarus, 2018-01-09 15:37 (2321 d 20:42 ago) – Posting: # 18153
Views: 3,358

Dear all,
We plan to conduct the bioequivalence study of levodopa and benserazide. We approached several experts to write a protocol of the study. However, they informed us that there is a substantial lack of information on the pharmacokinetics of benserazide to finalize the protocol. We probably cannot ask our competent authority for advice because they may not have necessary information. Thus, we have several important questions in relation to benserazide.

Should we quantify in serum only Benserazide or its metabolite, or both?

What are criteria for bioequivalence (bioequivalence should be established only on the levodopa data or on the data of both components? bioequivalence acceptance criteria?)?

What is the best design for the study?

Any suggestions where and from whom we can obtain reliable advice on the above-mentioned issues will be appreciated.

Edit: Category changed; see also this post #1. [Helmut]

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