atak
●    

2008-12-01 09:57
(6412 d 02:45 ago)

Posting: # 2842
Views: 4,978
 

 Sample size-Topically applied drug products [Power / Sample Size]

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Dear All,

How to calculate sample size for topically applied drug products? Is there any guidelines for conducting BE study for creams or gel?

thanks and regards,
Atatk
 
santosh.awale
☆    

Mumbai,
2008-12-05 06:24
(6408 d 06:19 ago)

@ atak
Posting: # 2881
Views: 3,772
 

 Sample size-Topically applied drug products

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Dear Atatk,
i am also in searching for the same. but you refere FDA guidlines for industry TOPICAL DERMATOLOGICAL DRUG PRODUCT NDA AND ANDA - IN VIVO BA, BE IN VITRO RELEASE AND ASSOCIATED STUDIES, and GUIDLINE FOR BIOEQUIVALENCE STUDIES OF GENERIC PRODUCT FOR TOPICAL USE (CHINA)
it may help you,
Regards
Santosh Awale.

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Edit: Full quote removed. Please see this post! [Helmut]
 
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