(1930 d 17:18 ago)
Posting: # 18915
Health Canada recently posted their updated BE guidances:
The effective date is July 1 (Canada day!)
Edit: Category changed; see also this post #1. [Helmut]
(1930 d 14:40 ago)
Posting: # 18916
❝ Health Canada recently posted their updated BE guidances:
THX for the notification! These are the first ones which are not only esthetic appealing but contain sumfink coming close to a change control.
No more BE based on urine data, pAUC for multiphasic release products (cut-off time(s) based on PD, not on PK like for the EMA).
This one in Section 2.3.1 is tricky:
In cases where more than two formulations are under study, or are studied under different conditions, a higher order design (that is (i.e.), more periods and sequences) should be considered. Since the intra‐subject error term of these designs has more degrees of freedom, smaller sample sizes are often adequate. The choice of a variance balanced design (Williams’ Design) or separate incomplete block design should be justified.It doesn’t matter whether a Williams’ design or Latin Squares are used. Crucial is the evaluation. I would always opt for separate incomplete blocks (see this post).
Unchanged but still questionable:
No big deal. Strange in
126.96.36.199 Highly variable drug products
In God we trust;
all others must bring data. W. Edwards Deming
❝ The effective date is July 1 (Canada day!)
Happy partying !
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
The quality of responses received is directly proportional to the quality of the question asked. 🚮
(1922 d 03:36 ago)
Posting: # 18976
Guidance Document of "Comparative Bioavailability Standards: Formulations Used for Systemic Effects" is updated and shall be effective from 01/07/2018 and applicable for submission after september 1 2018.
This guidance is now more descriptive in bioequivalce standards specially in critical and HVD proudcts.
Edit: Please don’t shout! Post moved to a related thread. [Helmut]