the Permitted Daily Exposure (PDE) value for the same Active Pharmaceutical Ingredient (API) can differ when used for veterinary and human applications in the context of cleaning validation in pharmaceuticals. You can use same formula, but ask toxicologist to provide PDE as per Veterinary. Even PDE value differ for each root of administration like, oral , injectable, dermal, Nasal spray etc
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HBEL-based MACO is a new concept for me. Thank you for sharing.
Hello
I wants your help
Pls reply me
Very nice to recap and current expection.
@@sandipmali1273 thank you
Sir how to calculate MACO for veternery drug to Human drug. Example carprofen to Dexketoprofen
the Permitted Daily Exposure (PDE) value for the same Active Pharmaceutical Ingredient (API) can differ when used for veterinary and human applications in the context of cleaning validation in pharmaceuticals. You can use same formula, but ask toxicologist to provide PDE as per Veterinary.
Even PDE value differ for each root of administration like, oral , injectable, dermal, Nasal spray etc
Is it mandatory to consider a safety factor in new approach?
@@mayurkale5357 No. In new approach safety factor is removed from MACO calculation.
Sir PDE ki calculation bi bata dy plz
@waqarking6801 ok will do small video on this