kishorpatil
☆    

2010-11-29 12:48
(5678 d 02:23 ago)

Posting: # 6243
Views: 4,468
 

 Selection of innovator product [Regulatives / Guidelines]

Deal all,
Can any body provide me innovator names of cefepime hydrochloride 2000mg and Amikacin sulfate 500mg for the BA/BE studies or which is the best innovator product for to Conduct the BA/BE studies of above mentioned drugs.


Regards
kishor Patil
Ohlbe
★★★

France,
2010-11-29 14:45
(5678 d 00:25 ago)

@ kishorpatil
Posting: # 6245
Views: 3,819
 

 Selection of innovator product

Dear Kishor,

As Helmut always says: the quality of the response is directly proportional to the quality of the question. If you don't specify for which market your trial is intended, nobody can tell you which reference product you should use (or even better, where to find this information yourself).

Please read this post before answering, so that we don't have to edit your post again.

Regards
Ohlbe

Regards
Ohlbe
kishorpatil
☆    

2010-12-09 05:45
(5668 d 09:25 ago)

@ Ohlbe
Posting: # 6276
Views: 3,791
 

 Selection of innovator product

Dear sir,

Thanks for u r reply.
The submission will be in following countries
1.South Africa
2.Korea
3.Australia

I hope u will provide details to me regarding Reference product of maxipime and Amikacin sulphate


Edit: Full quote removed. [Helmut]
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2010-12-09 06:19
(5668 d 08:51 ago)

@ kishorpatil
Posting: # 6278
Views: 3,806
 

 Block

Dear Kishor,

we warned you numerous times, the last time here.
You had the nerves to even include Ohlbe’s hint in your last post. :not really:

I blocked you from posting until January 1st, 2011. Congratulations – you are the first one in more than six years. And don’t think about returning as a sockpuppet in the meantime – I will resolve your IP.
Use your time for reading the Policy.


Edit: Unblocked with 2011-01-01. [Helmut]

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
pravin17
★    

India,
2010-12-13 10:55
(5664 d 04:15 ago)

(edited on 2010-12-13 13:23)
@ kishorpatil
Posting: # 6294
Views: 3,617
 

 Selection of innovator product

Kishor,

For Amikacin In Austrilia market ref you use DBL® Amikacin Injection

Pravin Borde



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! [Jaime]
pravin17
★    

India,
2010-12-13 10:26
(5664 d 04:44 ago)

(edited on 2010-12-13 13:24)
@ kishorpatil
Posting: # 6293
Views: 3,620
 

 Selection of innovator product

Dear Kishor,

For south africa submission you use MAXIPIME 2 g INJECTION as reference product (this is for cefepime).
and for Amikacin sulfate you take AMIKIN injection 500 mg as inovator.

Pravin Borde



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! [Jaime]
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