Mahesh M
★    

India,
2016-01-28 13:57
(2982 d 09:20 ago)

Posting: # 15876
Views: 2,361
 

 Newly Added Recommendations since December 31, 2015 (35 New; 12 Revisions) [Regulatives / Guidelines]

Dear All,

FDA release new product specific guidance.

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm

Fed study also should be conducted as per the revised recommendation of abiraterone.

Please share your thougts on that.
Regards
Helmut
★★★
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Vienna, Austria,
2016-01-28 16:10
(2982 d 07:06 ago)

@ Mahesh M
Posting: # 15881
Views: 2,127
 

 abiraterone: fasting+fed

Dear Mahesh,

❝ Fed study also should be conducted as per the revised recommendation of abiraterone.

❝ Please share your thougts on that.


See the comment in the guidance:
  • The reference listed drug (RLD) labeling indicates that abiraterone acetate tablets must be taken on an empty stomach. However, due to the complex food effects associated with abiraterone acetate tablets, FDA recommends applicants conduct a BE study under fed conditions.
Makes sense to me.

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