Bioequivalence and Bioavailability Forum

A-M-R ☆ Egypt, 2011-03-16 10:52 (5586 d 07:47 ago) Posting: # 6760 Views: 5,458	Atorvastatin, Sildenafil [Design Issues] Post reply
	What is the most suitable study design and sample size required to carry out bioequivalence studies for atorvastatin 40 mg tablets and sildenafil 100 mg tablets. very thanks Amr hussein Edit: Subject line changed. [Helmut]

Paresh
☆

2011-03-31 09:30
(5571 d 10:09 ago)

@ A-M-R
Posting: # 6842
Views: 4,228

Atorvastatin, Sildenafil

Post reply

Hi,

If you want to submit the study in US FDA than pls. find study design below.
For [image]

sildenafil and for [image]

atorvastatin.

And if EMEA submission need to conduct 2 study For sildenafil 2 way cross over study under fasting condition in healthy males and for atorvastatin partial replicate study (Pls. proof the HVDs using literature or pilot study) under fasting conditions in heathy males and females.

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Edit: Guidances linked. [Helmut]

Atorvastatin, Sildenafil [Design Issues]

Atorvastatin, Sildenafil