Bioequivalence and Bioavailability Forum

Mahesh M ★ India, 2016-01-28 13:57 (3004 d 07:44 ago) Posting: # 15876 Views: 2,395	Newly Added Recommendations since December 31, 2015 (35 New; 12 Revisions) [Regulatives / Guidelines] Post reply
	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
★★★

Vienna, Austria,
2016-01-28 16:10
(3004 d 05:31 ago)

@ Mahesh M
Posting: # 15881
Views: 2,157

abiraterone: fasting+fed

Dear Mahesh,

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

❝ Please share your thougts on that.

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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Helmut Schütz

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