ioanam
★    

Romania,
2009-02-17 20:15
(6340 d 10:04 ago)

Posting: # 3264
Views: 6,065
 

 omeprazole [Design Issues]

Dear all,
I would like to know if for omeprazole delayed release capsules (10 mg, 20 mg and 40 mg strengths) which of the following design is appropriate:
- single dose 40 mg fast, single dose 40 mg fed and multiple dose 40 mg (fast), associated with a biowaiver for 10, 20 and 40 mg.
or

- single dose fast 20 mg; single dose fed 20 mg; multiple dose 20 mg and multiple dose 40 mg associated with biowaiver for 10 and 20 mg.

I did not found certain information on linearity from 20 to 40 mg.
Thank you.
Helmut
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Vienna, Austria,
2009-02-17 20:28
(6340 d 09:51 ago)

@ ioanam
Posting: # 3265
Views: 5,334
 

 omeprazole (studies to be performed)

Dear Jo,

for which country/regulation?

FDA requires four studies:
  1. 40mg single dose, fasting
  2. 40mg single dose, sprinkle
  3. 40mg single dose, fed
  4. 20mg single dose, fasting
Biowaiver for 10mg based on acceptable in vivo BE on the 20mg strength, proportional similarity of the formulations on 10mg and 20mg strengths, and acceptable in vitro dissolution testing of 10mg and 20mg strengths.

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ioanam
★    

Romania,
2009-02-17 20:39
(6340 d 09:40 ago)

@ Helmut
Posting: # 3267
Views: 6,203
 

 omeprazole (studies to be performed)

For EU.
Helmut
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Vienna, Austria,
2009-03-06 18:03
(6323 d 12:16 ago)

@ ioanam
Posting: # 3334
Views: 5,094
 

 omeprazole (EU Q&A)

Dear Jo,

see here.

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Prashanth
☆    

2009-02-19 14:22
(6338 d 15:58 ago)

@ Helmut
Posting: # 3277
Views: 5,154
 

 omeprazole (studies to be performed)

Dear Helmut,

With respect to comments given to Jo, i would like to know 40mg single dose, sprinkle, Kindly let me know what is sprinkle

Best Regards,
Prashanth
Helmut
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Vienna, Austria,
2009-02-19 15:07
(6338 d 15:13 ago)

@ Prashanth
Posting: # 3278
Views: 5,264
 

 Sprinkle study

Dear Prashanth,

see this thread.

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Prashanth
☆    

2009-02-19 20:42
(6338 d 09:38 ago)

@ Helmut
Posting: # 3279
Views: 5,367
 

 Sprinkle study

Dear Helmut,

Thanks for updating me.....

Best Regards,
Prashanth
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