drgunasakaran1
★★  
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2014-05-15 06:05
(4430 d 18:34 ago)

Posting: # 12945
Views: 2,520
 

 FDA released Guidance for Industry ANDAs: Stability Testing [Regulatives / Guidelines]

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Dear all,
FDA released Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products – Questions and Answers
To read full guidance click here
—
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
 
Tina
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India,
2014-05-15 12:05
(4430 d 12:33 ago)

@ drgunasakaran1
Posting: # 12947
Views: 1,997
 

 FDA released Guidance for Industry ANDAs: Stability Testing

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Dear Dr.Gunasagaran,

Could you kindly state the impact of this guideline on FDA's expectation of test IMP stability data for planning studdies?

Kind regards,
Tina
 
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