What is clinically relevant? [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2018-04-04 16:49 (1298 d 12:51 ago) – Posting: # 18641
Views: 5,134

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 🖖
Helmut Schütz

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

Complete thread:

 Admin contact
21,753 posts in 4,548 threads, 1,544 registered users;
online 24 (0 registered, 24 guests [including 6 identified bots]).
Forum time: Sunday 05:41 CEST (Europe/Vienna)

They were “so intent of making everything numerical”
that they frequently missed seeing
what was there to be seen.    Barbara McClintock

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