Reply To: SPC review for Bibliographic products

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Please note, that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to guidelines and your own company procedures.  

Dear Member,

Thank you for your enquiry regarding SPC review for Bibliographic products.

One could compare an oral formulation with  injectable form with some rationale – if toxicity is Cmax driven, then it is likely that an injectable form will have higher Cmax, if it is AUC driven, then most of the toxicity for an injectable could be anticipated for oral, but there would be no local injection reactions or infusion reactions.

Kind regards

PIPA.