jag009
★★★

NJ,
2015-07-15 18:39
(3198 d 04:49 ago)

Posting: # 15088
Views: 7,353
 

 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
(3196 d 20:29 ago)

@ jag009
Posting: # 15098
Views: 6,059
 

 raloxifene

Between 30 - 45%.
d_labes
★★★

Berlin, Germany,
2015-07-17 10:05
(3196 d 13:23 ago)

@ Mauricio Sampaio
Posting: # 15099
Views: 6,018
 

 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
(3194 d 04:42 ago)

@ jag009
Posting: # 15105
Views: 5,963
 

 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 S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
jag009
★★★

NJ,
2015-07-20 08:42
(3193 d 14:46 ago)

@ drgunasakaran1
Posting: # 15106
Views: 5,838
 

 raloxifene CV

Thanks everyone.

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

John
UA Flag
Activity
 Admin contact
22,984 posts in 4,822 threads, 1,652 registered users;
47 visitors (0 registered, 47 guests [including 6 identified bots]).
Forum time: 23:29 CEST (Europe/Vienna)

You can’t fix by analysis
what you bungled by design.    Richard J. Light, Judith D. Singer, John B. Willett

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