Jay
☆    

India,
2014-11-11 07:21
(3426 d 03:50 ago)

Posting: # 13854
Views: 4,972
 

 Partial Replicate Study design for Pilot BE Study [Design Issues]

Dear friends,

For highly variable drugs with intrasubject CV more than 30% we go for partial replicate, reference replicated study design.

If we are proceeding with such HVDP, is the partial reference replicated study design for pilot study recommended?

Thanks in advance.

Regards,
Jay
Dr_Dan
★★  

Germany,
2014-11-11 10:08
(3426 d 01:03 ago)

@ Jay
Posting: # 13855
Views: 4,113
 

 Partial Replicate Study design for Pilot BE Study

Dear Jay
If you already know that the reference product is a HVDP what would be the advantage of a partial reference replicated study design for pilot study? Where is the gain of knowledge compared to a two-way crossover study? You might get a better idea of the magnitude of variability of the reference product (not your own formulation!, however, this could be important for studies according to EMA regulation). A Pilot study is needed to find out where you stand with your formulation and IMHO you should rather have more Test/Reference comparisons than comparisons within Reference.
I hope this helps.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan
Jay
☆    

India,
2014-11-11 12:03
(3425 d 23:08 ago)

@ Dr_Dan
Posting: # 13856
Views: 4,073
 

 Partial Replicate Study design for Pilot BE Study

Dear Dr_Dan,

Thanks for the reply.
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2014-11-11 12:31
(3425 d 22:40 ago)

@ Jay
Posting: # 13857
Views: 4,187
 

 Partial replicate pivotal study: why?

Dear Jay,

❝ For highly variable drugs with intrasubject CV more than 30% we go for partial replicate, reference replicated study design.


Why the lousy TRR|RRT|RTR? Hint: Search the forum.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
113 visitors (0 registered, 113 guests [including 10 identified bots]).
Forum time: 11:11 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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