What is clinically relevant? [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2018-04-04 16:49 (1596 d 02:20 ago) – Posting: # 18641
Views: 5,329

Hi BF,

» A mix of liposomal-bound and free doxorubicin is infused, …

Are you sure? I know only liposome-encapsulated formulations (i.e., containing no free doxorubicin).

I agree that the FDA’s guidance (asking for AUC and Cmax of free and liposome-encapsulated doxorubicin) might not sufficiently enough characterize the profiles.

There is no product-specific guidance in Europe so far. However, current regulatory practice on this side of the pond is much more strict.
PK metrics for encapsulated, free, and total doxorubicin:PK metrics for the primary metabolite doxorubicinol: As above but supportive only.

Problems are manifold:IMHO, encapsulated and total doxorubicin are not relevant from a clinical perspective – only nice to know. I would prefer to assess just the metabolite but all of its PK metrics in a confirmatory manner.

BTW, at the 3rd GBHI conference (Amsterdam, April 12–13) Session IV will be devoted to liposomal parenteral preparations. Let’s wait for regulators’ unfathomable wisdom.

Dif-tor heh smusma 🖖 [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,305 posts in 4,668 threads, 1,587 registered users;
online 11 (1 registered, 10 guests [including 6 identified bots]).
Forum time: Wednesday 19:10 CEST (Europe/Vienna)

There is no point in being precise when you don’t know
what you’re talking about.    attributed to John Tukey

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5