Pharma_88
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India,
2021-04-13 08:31
(1336 d 19:51 ago)

Posting: # 22306
Views: 2,249
 

 Cataplasms and study design [Regulatives / Guidelines]

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Dear All,

For the formulations i.e. cataplasms, is it required to conduct skin sensitization as well as skin irritation study? any article that can help us to understand formulation type and above mentioning study requirements?

thanks,
Pharma88
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Regards,
Pharma_88
 
drgunasakaran1
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2021-05-13 08:43
(1306 d 19:39 ago)

@ Pharma_88
Posting: # 22350
Views: 1,620
 

 Cataplasms and study design

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Dear Mr Pharma88,

Which country of submission.?

Based on the country of submission, poultice/cataplasms formulation may require skin irritation and sensitization (I/S) studies.
—
Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
 
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