Dr.Pravin
☆    

Ahmedabad,
2006-12-06 15:17
(6322 d 03:42 ago)

Posting: # 382
Views: 3,917
 

 Bioequivalence criteria for study [Regulatives / Guidelines]

I am conducting one study of highly variable drug for EU, i have defineed the range for the BE limit is 80 to 125% for that drug. The problem is that i have completed the one period of that study, now i want to change the BE criteria, so what is more fesible, protocol deviation or protocol amendment?

Dr.Pravin Ahir
Co-Investigator,
Accutest Research Pvt.Lab.(I), Ltd.
Ahmedabad
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2006-12-06 15:50
(6322 d 03:10 ago)

@ Dr.Pravin
Posting: # 383
Views: 3,009
 

 BE criteria changed after period 1

Dear Dr. Pravin!

❝ I am conducting one study of highly variable drug for EU, i have defineed the range for the BE limit is 80 to 125 % for that drug.


Assuming a conventional 2×2 design: nice, so your study is planned for completion of 40+ subjects ;-)

❝ The problem is that i have completed the one period of that study, now i want to change the BE criteria,...


Why?
Based on which new information...
How?
Widening of the interval is almost impossible according to the Questions & Answers Document; the Concept Paper for HVDs/HVDPs is expected to be implemented in July 2007(!)

❝ ...so what is more fesible, protocol deviation or protocol amendment?


Oh, I think you are in deep trouble. If you change the acceptance range, the sample size needed to demonstrate BE also changes.
You cannot simply change the design of a study and just report a 'protocol violation'.
Therefore according to EU regulations an amendment must be prepared which would be rated as 'substantial', and approval from both the IEC and the regulatory body must be obtained.
Even if you want to change your design from a simple 2×2 design to a replicated design, it will be difficult to randomize the 'extra' periods.
Whatever your washout period is, it will be impossible to get the necesarry paperwork to be done in time.

You should think it over again, and/or provide us with more informations (especially your reasons).

P.S.: Instructions.htm#Plt, please!

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;
79 visitors (0 registered, 79 guests [including 10 identified bots]).
Forum time: 19:00 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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