raghu
★    

India,
2008-11-04 13:17
(6447 d 14:06 ago)

Posting: # 2625
Views: 15,294
 

 BE study for Topically administered drug products [Design Issues]

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1. Is there any USFDA or any other guidelines for conducting the BE study for Topically applied dosage formulations

2. whether Pk and Pd both parameters to be analysed or only Pharmacodynamics to be evaluated to show bioequivalence ???

thanks
raghavender
 
Jaime_R
★★  

Barcelona,
2008-11-04 13:33
(6447 d 13:49 ago)

@ raghu
Posting: # 2626
Views: 6,961
 

 Guidelines for Topicals

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Dear Raghu,

please search the Guidance collection before posting (hints: Europe, Japan).
—
Regards, Jaime
 
santosh.awale
☆    

Mumbai,
2008-12-05 09:22
(6416 d 18:01 ago)

(edited on 2008-12-05 09:59)
@ raghu
Posting: # 2884
Views: 6,687
 

 BE study for Topically administered drug products

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Dear raghvender
serch for this "TOPICAL DERMATOLOGICAL DRUG PRODUCT NDA AND ANDA - IN VIVO BA, BE IN VITRO RELEASE AND ASSOCIATED STUDIES" for USFDA,
for bioequivalence you go for pk only. but some time pharmacodynamic also necessery to show bioequivalence e.g. dermatopharmacokinetic of corticosteroid

regards,
Santosh A.
--
Edit: Full quote removed. Please see this post! [Ohlbe]
 
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