mittyri
★★  

Russia,
2019-04-02 12:32

Posting: # 20111
Views: 531
 

 Pharmacokinetic Solidarity? [BE/BA News]

Dear Colleagues!

I'm looking into April Fools' Day joke by EMA.
Could some of you shade more light regarding that?
Are there any scientific papers where lack of bioequivalence was demonstrated due to absence of PK Solidarity?
Eagerly waiting for 'modified Wagner-Nelson method, the details of which will be added to the Q&A on the website'.

Kind regards,
Mittyri
nobody
nothing

2019-04-02 12:39

@ mittyri
Posting: # 20112
Views: 483
 

 Pharmacokinetic Solidarity?

...don't invest too much time, from 01-OCT-2021 EMA will accept BE only based on portal vein concentrations of drugs.

Kindest regards, nobody
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2019-04-02 13:00

@ nobody
Posting: # 20113
Views: 471
 

 Pharmacokinetic Solidarity?

Furthermore, the EMA is considering the FDA’s definition as laid down in CFR21§320.23(a)(1) for locally acting drugs

[…] scientifically valid measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
(my emphasis)

and will require biopsies as of April 1st, 2022.

Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
nobody
nothing

2019-04-02 13:37

@ Helmut
Posting: # 20114
Views: 468
 

 Pharmacokinetic Solidarity?


Kindest regards, nobody
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