santosh.awale
☆    

Mumbai,
2008-12-06 13:48
(6406 d 10:45 ago)

Posting: # 2888
Views: 4,629
 

 Truncated or Parallel Design [Design Issues]

Hi to all,
when tel is equal or more than 24 hours, then we will go for Truncated, but what is limit for tel for Truncated design? when we go for parallel design (what is limit for tel for parallel design)?
give your comments........


thank you and regards,
Santosh A.
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2008-12-06 17:18
(6406 d 07:15 ago)

@ santosh.awale
Posting: # 2890
Views: 3,930
 

 Truncated or Parallel Design

Dear Santosh!

❝ when tel is equal or more than 24 hours, then we will go for

❝ Truncated, but what is limit for tel for Truncated design? when

❝ we go for parallel design (what is limit for tel for parallel

❝ design)?


There's no agreement, but Canada suggested 24 hours in 2005. The European Draft Guideline from 2008 suggested no sampling beyond 72 hours for all IR formulations irrespective of the half-life.

❝ when we go for parallel design (what is limit for tel for

❝ parallel design)?


It's up to you. ± points you should consider:
- Power (for a given sample size) in a parallel design is lower than in a cross-over
+ Less chance for drop-outs in a long wash-out

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
santosh.awale
☆    

Mumbai,
2008-12-08 08:02
(6404 d 16:31 ago)

@ Helmut
Posting: # 2892
Views: 3,747
 

 Truncated or Parallel Design

Dear Helmut sir,
thank you for giving suggesion and link.

thanks a lot,
with regards,
Santosh A.
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
125 visitors (0 registered, 125 guests [including 16 identified bots]).
Forum time: 01:34 CEST (Europe/Vienna)

Science is simply common sense at its best that is,
rigidly accurate in observation, and
merciless to fallacy in logic.    Thomas Henry Huxley

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