jag009
★★★

NJ,
2015-07-15 18:39
(4002 d 01:56 ago)

Posting: # 15088
Views: 9,389
 

 raloxifene [Design Issues]

Hi all,

Does anyone have experience with raloxifene? If so, what is the intrasubject cv? According to literature it's a HVD (ISCV>=30) but no exact figure.

Thanks
John


Edit: Category changed. [Helmut]
Mauricio Sampaio
★    

Brazil,
2015-07-17 02:59
(4000 d 17:37 ago)

@ jag009
Posting: # 15098
Views: 7,649
 

 raloxifene

Between 30 - 45%.
d_labes
★★★

Berlin, Germany,
2015-07-17 10:05
(4000 d 10:31 ago)

@ Mauricio Sampaio
Posting: # 15099
Views: 7,639
 

 raloxifene CV

Hi John, hi Mauricio,

❝ Between 30 - 45%.


Confirmed if CV for Cmax is meant:
1 study pivotal 36 subj. in 2005: CV(Cmax) ~29%; CV(AUC) ~22%
1 study pilot, 12 subj. in 2010: CV(Cmax) ~41%; CV(AUC) ~ 15%

Regards,

Detlew
drgunasakaran1
★★  
avatar

2015-07-19 18:46
(3998 d 01:49 ago)

@ jag009
Posting: # 15105
Views: 7,583
 

 raloxifene

Dear Mr John,

❝ Does anyone have experience with raloxifene? If so, what is the intrasubject cv? According to literature it's a HVD (ISCV>=30) but no exact figure.


The literature reported Intrasubject variability of Raloxifene for Cmax was 39.59% as per the bioequivalence study submitted to EMA.

Reference: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001075/WC500091423.pdf

Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
jag009
★★★

NJ,
2015-07-20 08:42
(3997 d 11:54 ago)

@ drgunasakaran1
Posting: # 15106
Views: 7,477
 

 raloxifene CV

Thanks everyone.

PS Thanks v much for link drgunasakaran1. That is very helpful!

John
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